Elecsys TSH 07028091190Recalls & reported problems

Summary

The FDA's MAUDE database contains 25 adverse event reports that list this exact device (DI 04015630939831), received between Jul 12, 2018 and Nov 13, 2023 — classified as 25 malfunctions.

The most frequently reported specific device problem is “High Test Results” (16 reports).

3 other recalls cover devices cleared under the same FDA submission (K162606); they may or may not involve this specific model.

Reports come from manufacturers, hospitals and patients and are not verified by the FDA. A report does not prove the device caused the event, and counts can't be used to compare devices or estimate failure rates. What reports can and can't tell you · How this data works · Data updated Oct 18, 2026.

Most reported problems

Recent adverse event reports

The 25 most recent of 25 reports, in the reporter's own words as published by the FDA.

• MalfunctionNov 13, 2023Low Test Results; Non Reproducible Results; Low Test Results; Non Reproducible Results

  THERE WAS AN ALLEGATION OF QUESTIONABLE ELECSYS TSH ASSAY RESULTS FOR 1 PATIENT SAMPLE ON A COBAS E 801 ANALYTICAL UNIT. THE INITIAL TSH RESULT WAS 0.0207 UIU/ML. THE REPEAT RESULT WAS 3.71 UIU/ML. THE SAMPLE WAS REPEATED ON ANOTHER ANALYZER AND THE RESULT WAS 3.75 UIU/ML.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 18120048 ↗
• MalfunctionJul 12, 2021High Test Results; High Test Results

  THE INITIAL REPORTER RECEIVED QUESTIONABLE ELECSYS TSH ASSAY AND ELECSYS FT4 III ASSAY RESULTS FOR ONE PATIENT TESTED ON A COBAS 8000 E 801 MODULE. THE E 801 MODULE SERIAL NUMBER WAS REQUESTED BUT NOT PROVIDED. THE PATIENT HAD A SAMPLE COLLECTED ON (B)(6) 2020 AND ON (B)(6) 2021. THE TSH AND FT4 RESULTS WERE REPORTED OUTSIDE THE LABORATORY. THE PHYSICIAN QUESTIONED THE RESULTS AND ASKED FOR RE-MEASUREMENT OF THE SAMPLES. THE CUSTOMER PROVIDED THE SAMPLES FOR AN INVESTIGATION AND THE SAMPLES WERE TESTED ON A COBAS 8000 E 801 MODULE, COBAS E 411 IMMUNOASSAY ANALYZER, AND AN ABBOTT ARCHITECT. REFER TO THE ATTACHMENT ON THE MEDWATCH FOR ALL THE PATIENT DATA. THIS MDR IS FOR TSH V1 ASSAY. REFER TO THE MEDWATCH WITH PATIENT IDENTIFIER (B)(6) FOR TSH V2 ASSAY AND (B)(6) FOR FT4 III ASSAY.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 12150494 ↗
• MalfunctionJul 8, 2021High Test Results; High Test Results

  THE INITIAL REPORTER RECEIVED QUESTIONABLE ELECSYS TSH ASSAY RESULTS FOR ONE PATIENT TESTED ON A COBAS 8000 E 801 MODULE. THE E 801 MODULE SERIAL NUMBER WAS REQUESTED BUT NOT PROVIDED. THE PATIENT'S INITIAL ELECSYS TSH RESULT WAS REPORTED OUTSIDE THE LABORATORY. THE PHYSICIAN QUESTIONED THE ELECSYS TSH RESULT AND REQUESTED RE-MEASUREMENT OF THE PATIENT'S SAMPLE. THE CUSTOMER PERFORMED REPEAT TESTING ON AN ABBOTT ARCHITECT ANALYZER. THE CUSTOMER SENT THE SAMPLE FOR INVESTIGATION AND THE PATIENT'S SAMPLE WAS TESTED ON AN E 801 MODULE AND A COBAS E 411 IMMUNOASSAY ANALYZER. THE CUSTOMER'S E 801 MODULE SERIAL NUMBER WAS REQUESTED BUT NOT PROVIDED. THIS MEDWATCH IS FOR TSH ASSAY VERSION REFER TO THE MEDWATCH WITH PATIENT IDENTIFIER (B)(6) FOR THE TSH ASSAY VERSION 2.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 12136277 ↗
• MalfunctionNov 27, 2019High Test Results; High Test Results

  THE INITIAL REPORTER STATED THEY RECEIVED DISCREPANT RESULTS FOR ONE PATIENT SAMPLE TESTED WITH THE ELECSYS TSH ASSAY, THE ELECSYS FT4 III ASSAY, ELECSYS FT3 III, THE ELECSYS T4 ASSAY, ELECSYS T3, AND THE ELECSYS ANTI-TSHR IMMUNOASSAY ON A COBAS 8000 E 801 MODULE AND A SECOND E 801 MODULE USED FOR INVESTIGATION. NO INCORRECT RESULTS WERE REPORTED OUTSIDE OF THE LABORATORY. THIS MEDWATCH WILL APPLY TO THE TSH ASSAY. PLEASE REFER TO THE MEDWATCH WITH PATIENT IDENTIFIER (B)(6) FOR INFORMATION RELATED TO THE FT4 ASSAY, REFER TO THE MEDWATCH WITH PATIENT IDENTIFIER (B)(6) FOR INFORMATION RELATED TO THE FT3 ASSAY, REFER TO THE MEDWATCH WITH PATIENT IDENTIFIER (B)(6) FOR INFORMATION RELATED TO THE T4 ASSAY, REFER TO THE MEDWATCH WITH PATIENT IDENTIFIER (B)(6) FOR INFORMATION RELATED TO THE T3 ASSAY, AND REFER TO THE MEDWATCH WITH PATIENT IDENTIFIER (B)(6) FOR INFORMATION RELATED TO THE ANTI-TSHR ASSAY. THE SAMPLE WAS INITIALLY TESTED ON THE CUSTOMER'S E 801 ANALYZER ON (B)(6) 2019. THE SAMPLE WAS REPEATED USING THE ARCHITECT METHOD (FOR TSH, FT4, FT3, T4, T3) AND YAMASA METHOD (FOR ANTI-TSHR). THE SAMPLE WAS PROVIDED FOR INVESTIGATION WHERE IT WAS TESTED ON A SECOND E 801 ANALYZER ON (B)(

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 9384222 ↗
• MalfunctionNov 8, 2018High Test Results; High Test Results

  THE CUSTOMER STATED THAT THEY RECEIVED ERRONEOUS RESULTS FOR ONE PATIENT SAMPLE TESTED WITH THE ELECSYS TSH ASSAY, ELECSYS FT3 III, THE ELECSYS FT4 III ASSAY, AND ROCHE DIAGNOSTICS COBAS ELECSYS ANTI-TPO ON A COBAS 8000 E 801 MODULE. THE SAMPLE ALSO HAD AN ERRONEOUS RESULT FOR THE ELECSYS FT4 II ASSAY WHEN TESTED ON A SECOND E 801 ANALYZER USED FOR INVESTIGATION. THIS MEDWATCH WILL APPLY TO THE ANTI-TPO ASSAY. PATIENT IDENTIFIERS FOR INFORMATION RELATED TO EACH OTHER AFFECTED ASSAY: (B)(6) = TSH, (B)(6) = FT3, (B)(6) = FT4 III, (B)(6) = ANTI-TPO. REFER TO THE ATTACHMENT FOR ALL PATIENT DATA. THE SAMPLE WAS TESTED ON THE CUSTOMER'S E 801 ANALYZER, THEN TESTED ON ABBOTT ARCHITECT ANALYZERS AT THE CUSTOMER SITE AND ANOTHER LABORATORY. THE SAMPLE WAS PROVIDED FOR INVESTIGATION WHERE IT WAS TESTED ON A SECOND E 801 ANALYZER. MEASUREMENTS FOR TSH, FT3, AND FT4 III WERE PERFORMED ON THE E 801 ANALYZER USED FOR INVESTIGATION ON (B)(6) 2018. MEASUREMENTS FOR FT4 II AND ANTI-TPO WERE PERFORMED ON THE E 801 ANALYZER USED FOR INVESTIGATION ON (B)(6) 2018. NO ADVERSE EVENTS WERE ALLEGED TO HAVE OCCURRED WITH THE PATIENT. THE E 801 ANALYZER USED AT THE CUSTOMER SITE IS SERIAL NUMBER (B)(4). THE

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 8052445 ↗
• MalfunctionNov 2, 2018Low Test Results; Low Test Results

  THE CUSTOMER STATED THAT THEY RECEIVED ERRONEOUS RESULTS FOR ONE PATIENT SAMPLE TESTED WITH THE ELECSYS TSH ASSAY, ELECSYS FT3 III, THE ELECSYS FT4 III ASSAY, AND ROCHE DIAGNOSTICS COBAS ELECSYS ANTI-TPO ON A COBAS 8000 E 801 MODULE. THE SAMPLE ALSO HAD AN ERRONEOUS RESULT FOR THE ELECSYS FT4 II ASSAY WHEN TESTED ON A SECOND E 801 ANALYZER USED FOR INVESTIGATION. THIS MEDWATCH WILL APPLY TO THE TSH ASSAY. PLEASE REFER TO THE MEDWATCHES WITH THE FOLLOWING. PATIENT IDENTIFIERS FOR INFORMATION RELATED TO EACH OTHER AFFECTED ASSAY: (B)(6) = FT3; (B)(6) = FT4 III; (B)(6) = ANTI-TPO; (B)(6) = FT4 II. REFER TO THE ATTACHMENT FOR ALL PATIENT DATA. THE SAMPLE WAS TESTED ON THE CUSTOMER'S E 801 ANALYZER, THEN TESTED ON ABBOTT ARCHITECT ANALYZERS AT THE CUSTOMER SITE AND ANOTHER LABORATORY. THE SAMPLE WAS PROVIDED FOR INVESTIGATION WHERE IT WAS TESTED ON A SECOND E 801 ANALYZER. MEASUREMENTS FOR TSH, FT3, AND FT4 III WERE PERFORMED ON THE E 801 ANALYZER USED FOR INVESTIGATION ON (B)(6) 2018. MEASUREMENTS FOR FT4 II AND ANTI-TPO WERE PERFORMED ON THE E 801 ANALYZER USED FOR INVESTIGATION ON (B)(6) 2018. NO ADVERSE EVENTS WERE ALLEGED TO HAVE OCCURRED WITH THE PATIENT. THE E 801 ANALYZER USED A

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 8032766 ↗
• MalfunctionNov 2, 2018High Test Results; High Test Results

  THE CUSTOMER STATED THAT THEY RECEIVED ERRONEOUS RESULTS FOR ONE PATIENT SAMPLE TESTED WITH THE ELECSYS TSH ASSAY, ELECSYS FT3 III, THE ELECSYS FT4 III ASSAY, AND ROCHE DIAGNOSTICS COBAS ELECSYS ANTI-TPO ON A COBAS 8000 E 801 MODULE. THE SAMPLE ALSO HAD AN ERRONEOUS RESULT FOR THE ELECSYS FT4 II ASSAY WHEN TESTED ON A SECOND E 801 ANALYZER USED FOR INVESTIGATION. THIS MEDWATCH WILL APPLY TO THE ANTI-TPO ASSAY. PLEASE REFER TO THE MEDWATCHES WITH THE FOLLOWING . PATIENT IDENTIFIERS FOR INFORMATION RELATED TO EACH OTHER AFFECTED ASSAY: (B)(6) = TSH ; (B)(6) = FT3 ; (B)(6) = FT4 III ; (B)(6) = FT4 II . REFER TO THE ATTACHMENT FOR ALL PATIENT DATA. THE SAMPLE WAS TESTED ON THE CUSTOMER'S E 801 ANALYZER, THEN TESTED ON ABBOTT ARCHITECT ANALYZERS AT THE CUSTOMER SITE AND ANOTHER LABORATORY. THE SAMPLE WAS PROVIDED FOR INVESTIGATION WHERE IT WAS TESTED ON A SECOND E 801 ANALYZER. MEASUREMENTS FOR TSH, FT3, AND FT4 III WERE PERFORMED ON THE E 801 ANALYZER USED FOR INVESTIGATION ON (B)(6) 2018. MEASUREMENTS FOR FT4 II AND ANTI-TPO WERE PERFORMED ON THE E 801 ANALYZER USED FOR INVESTIGATION ON (B)(6) 2018. NO ADVERSE EVENTS WERE ALLEGED TO HAVE OCCURRED WITH THE PATIENT. THE E 801 ANALYZER U

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 8032731 ↗
• MalfunctionOct 22, 2018High Test Results; High Test Results

  THE CUSTOMER RECEIVED QUESTIONABLE THYROID RESULTS FOR TWO SAMPLES FROM ONE PATIENT FROM THE COBAS 8000 E 801 MODULE. THE SAMPLE WAS THEN TESTED ON AN ARCHITECT ANALYZER AND SUBMITTED FOR INVESTIGATION WHERE IT WAS TESTED ON A COBAS 8000 E 801 MODULE, COBAS 6000 E602 MODULE, AND A COBAS E 411 IMMUNOASSAY ANALYZER. REFER TO THE MEDWATCH WITH THE FOLLOWING PATIENT IDENTIFIERS: (B)(6) ELECSYS TSH ASSAY; (B)(6) ELECSYS FT4 ASSAY; (B)(6) ELECSYS FT3 III. THE ERRONEOUS RESULTS WERE REPORTED OUTSIDE OF THE LABORATORY. THERE WAS NO ALLEGATION OF AN ADVERSE EVENT. THE INVESTIGATION DID NOT IDENTIFY A PRODUCT PROBLEM. THE CAUSE OF THE EVENT COULD NOT BE DETERMINED AS NO SAMPLE WAS AVAILABLE FOR FURTHER INVESTIGATION. FROM THE INFORMATION PROVIDED, A GENERAL REAGENT ISSUE COULD MOST LIKELY BE EXCLUDED. THE DIFFERENCES IN THE VALUES MOST LIKELY RELATE TO THE DIFFERENT SETUPS OF THE ASSAY, THE DIFFERENT ANTIBODIES USED, AND THE DIFFERENT STANDARDIZATION MATERIALS/PROCEDURES USED.

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 7991559 ↗
• MalfunctionOct 19, 2018High Test Results; High Test Results

  THE CUSTOMER QUESTIONED THYROID RESULTS FOR 7 PATIENT SAMPLES TESTED FOR ELECSYS TSH (TSH), ELECSYS FT4 III (FT4 III), AND ELECSYS FT3 III (FT3 III) ON A COBAS E 801 MODULE. THE 7 PATIENT SAMPLES WERE SUBMITTED FOR INVESTIGATION WHERE DISCREPANT RESULTS WERE IDENTIFIED FOR TSH, FT4 III AND FT3 III BETWEEN THE CUSTOMER'S E801 MODULE, THE CENTAUR METHOD, AN E801 MODULE USED AT THE INVESTIGATION SITE, A COBAS 8000 E 602 MODULE USED AT THE INVESTIGATION SITE AND A COBAS E 411 IMMUNOASSAY ANALYZER USED AT THE INVESTIGATION SITE. IT IS NOT KNOWN IF ANY INCORRECT RESULTS WERE REPORTED OUTSIDE OF THE LABORATORY. THIS MEDWATCH WILL COVER TSH. REFER TO MEDWATCH WITH PATIENT IDENTIFIER (B)(6) FOR INFORMATION ON THE FT4 III RESULTS AND MEDWATCH WITH PATIENT IDENTIFIER (B)(6) FOR INFORMATION ON THE FT3 III RESULTS. THERE WAS NO ALLEGATION THAT AN ADVERSE EVENT OCCURRED. THE SERIAL NUMBER FOR THE CUSTOMER'S E801 MODULE WAS NOT PROVIDED. THE E602 MODULE SERIAL NUMBER WAS (B)(4). THE E411 ANALYZER SERIAL NUMBER WAS (B)(4). THE E801 MODULE SERIAL NUMBER USED AT THE INVESTIGATION SITE WAS (B)(4). THE TSH REAGENT LOT NUMBER USED WITH THE E602 MODULE WAS 341699 WITH AN EXPIRATION DATE OF 28-FEB-2019.

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 7985210 ↗
• MalfunctionOct 12, 2018High Test Results; High Test Results

  THE CUSTOMER QUESTIONED RESULTS FOR 1 PATIENT SAMPLE TESTED FOR ELECSYS TSH, ELECSYS FT4 II AND ELECSYS FT3 III ON A COBAS E 801 MODULE. THE PATIENT SAMPLE WAS SUBMITTED FOR INVESTIGATION WHERE DISCREPANT RESULTS WERE IDENTIFIED FOR TSH AND FT3 III BETWEEN THE CUSTOMER'S E801 MODULE, THE CENTAUR METHOD AND AN E801 MODULE USED AT THE INVESTIGATION SITE. THE INITIAL RESULTS FROM THE CUSTOMER SITE WERE REPORTED OUTSIDE OF THE LABORATORY. THIS MEDWATCH WILL COVER TSH. REFER TO MEDWATCH WITH PATIENT IDENTIFIER (B)(6) FOR INFORMATION ON THE FT3 III RESULTS. REFER TO ATTACHED DATA FOR THE PATIENT RESULTS. THERE WAS NO ALLEGATION THAT AN ADVERSE EVENT OCCURRED. THE SERIAL NUMBER FOR THE CUSTOMER'S E801 MODULE WAS NOT PROVIDED. THE E801 MODULE SERIAL NUMBER USED AT THE INVESTIGATION SITE WAS (B)(4). THE TSH REAGENT LOT NUMBER USED WITH THE E801 MODULE AT THE INVESTIGATION SITE WAS 331814 WITH AN EXPIRATION DATE OF AUG-2019.

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 7961315 ↗
• MalfunctionOct 2, 2018Non Reproducible Results; Non Reproducible Results

  THE CUSTOMER COMPLAINED OF QUESTIONABLE THYROID RESULTS FOR 1 PATIENT SAMPLE TESTED ON A COBAS 8000 E 801 MODULE COMPARED TO THE RESULTS FROM BOTH A WAKO AND ARCHITECT INSTRUMENT. FROM THE DATA PROVIDED, A REPORTABLE MALFUNCTION WAS PROVIDED FOR ELECSYS TSH ASSAY AND ELECSYS FT3 III. THIS MEDWATCH WILL COVER THE TSH. PATIENT IDENTIFIER (B)(6) FOR INFORMATION ON FT3 III. THE DISCREPANT RESULTS ARE HIGHLIGHTED. THE ERRONEOUS RESULTS WERE RELEASED OUTSIDE OF THE LABORATORY. THERE WAS NO ALLEGATION OF AN ADVERSE EVENT. THE COBAS E801 SERIAL NUMBER USED AT THE CUSTOMER'S SITE WAS (B)(4). THE COBAS E801 SERIAL NUMBER USED AT THE INVESTIGATION SITE WAS (B)(4). THE FT3 III REAGENT LOT USED AT THE INVESTIGATION SITE WAS LOT 314824 WITH AN EXPIRATION DATE OF MAY-2019. THE TSH REAGENT LOT USED AT THE INVESTIGATION SITE WAS LOT 331814 WITH AN EXPIRATION DATE OF AUG-2019. THE INVESTIGATION IS CURRENTLY ONGOING.

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 7926428 ↗
• MalfunctionOct 1, 2018High Test Results; High Test Results

  THE CUSTOMER QUESTIONED THYROID RESULTS FOR 3 PATIENT SAMPLES TESTED FOR ELECSYS TSH, ELECSYS FT4 III, AND ELECSYS FT3 III ON A COBAS E801 MODULE. THE 3 PATIENT SAMPLES WERE SUBMITTED FOR INVESTIGATION WHERE DISCREPANT RESULTS WERE IDENTIFIED FOR TSH AND FT3 III BETWEEN THE CUSTOMER'S E801 MODULE, THE SIEMENS CENTAUR METHOD, AN E801 MODULE USED AT THE INVESTIGATION SITE, A COBAS 8000 E 602 MODULE USED AT THE INVESTIGATION SITE AND A COBAS E 411 IMMUNOASSAY ANALYZER USED AT THE INVESTIGATION SITE. IT IS NOT KNOWN IF ANY INCORRECT RESULTS WERE REPORTED OUTSIDE OF THE LABORATORY. THIS MEDWATCH WILL COVER TSH. REFER TO MEDWATCH WITH PATIENT IDENTIFIER (B)(6) FOR INFORMATION ON THE FT3 III RESULTS. THERE WAS NO ALLEGATION OF AN ADVERSE EVENT. THE SERIAL NUMBER FOR THE CUSTOMER'S E801 MODULE WAS NOT PROVIDED. THE E602 MODULE SERIAL NUMBER WAS (B)(4). THE E411 ANALYZER SERIAL NUMBER WAS (B)(4). THE E801 MODULE SERIAL NUMBER USED AT THE INVESTIGATION SITE WAS (B)(4). THE TSH REAGENT LOT NUMBER USED WITH THE E602 MODULE WAS 341699 WITH AN EXPIRATION DATE OF 28-FEB-2019. THE TSH REAGENT LOT NUMBER USED WITH THE E411 ANALYZER WAS 328081 WITH AN EXPIRATION DATE OF 31-DEC-2018. THE TSH REAGENT

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 7923043 ↗
• MalfunctionOct 1, 2018High Test Results; High Test Results

  THE CUSTOMER QUESTIONED THYROID RESULTS FOR 2 PATIENT SAMPLES TESTED FOR ELECSYS TSH (TSH), ELECSYS FT4 III (FT4 III), AND ELECSYS FT3 III (FT3 III) ON A COBAS E 801 MODULE. THE 2 PATIENT SAMPLES WERE SUBMITTED FOR INVESTIGATION WHERE DISCREPANT RESULTS WERE IDENTIFIED FOR TSH AND FT3 III BETWEEN THE CUSTOMER'S E801 MODULE, THE CENTAUR METHOD, AN E801 MODULE USED AT THE INVESTIGATION SITE, A COBAS 8000 E 602 MODULE USED AT THE INVESTIGATION SITE AND A COBAS E 411 IMMUNOASSAY ANALYZER USED AT THE INVESTIGATION SITE. IT IS NOT KNOWN IF ANY INCORRECT RESULTS WERE REPORTED OUTSIDE OF THE LABORATORY. THIS MEDWATCH WILL COVER TSH. REFER TO MEDWATCH WITH PATIENT IDENTIFIER (B)(4) FOR INFORMATION ON THE FT3 III RESULTS. REFER TO ATTACHED DATA TITLED "PATIENT RESULTS" FOR THE PATIENT RESULTS. THERE WAS NO ALLEGATION THAT AN ADVERSE EVENT OCCURRED. THE SERIAL NUMBER FOR THE CUSTOMER'S E801 MODULE WAS NOT PROVIDED. THE E602 MODULE SERIAL NUMBER WAS (B)(4). THE E411 ANALYZER SERIAL NUMBER WAS (B)(4). THE E801 MODULE SERIAL NUMBER USED AT THE INVESTIGATION SITE WAS (B)(4). THE TSH REAGENT LOT NUMBER USED WITH THE E602 MODULE WAS 341699 WITH AN EXPIRATION DATE OF 28-FEB-2019. THE TSH REAGENT LOT

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 7922514 ↗
• MalfunctionSep 19, 2018High Test Results; High Test Results

  THE CUSTOMER QUESTIONED THYROID RESULTS FOR 3 PATIENT SAMPLES TESTED FOR ELECSYS FT3 III (FT3 III), ELECSYS FT4 III (FT4 III) AND ELECSYS TSH (TSH) ON A COBAS E 801 MODULE. THE 3 PATIENT SAMPLES WERE SUBMITTED FOR INVESTIGATION WHERE DISCREPANT RESULTS WERE IDENTIFIED FOR FT3 III, FT4 III AND TSH BETWEEN THE CUSTOMER'S E801 MODULE, THE CENTAUR METHOD, AN E801 MODULE USED AT THE INVESTIGATION SITE, A COBAS 8000 E 602 MODULE USED AT THE INVESTIGATION SITE AND A COBAS E 411 IMMUNOASSAY ANALYZER USED AT THE INVESTIGATION SITE. IT IS NOT KNOWN IF ANY INCORRECT RESULTS WERE REPORTED OUTSIDE OF THE LABORATORY. THIS MEDWATCH WILL COVER TSH. REFER TO MEDWATCH WITH PATIENT IDENTIFIER (B)(6) FOR INFORMATION ON THE FT4 III RESULTS AND MEDWATCH WITH PATIENT IDENTIFIER (B)(6) FOR INFORMATION ON THE FT3 III RESULTS. THERE WAS NO ALLEGATION THAT AN ADVERSE EVENT OCCURRED. THE SERIAL NUMBER FOR THE CUSTOMER'S E801 MODULE WAS NOT PROVIDED. THE PATIENT SAMPLES WERE ALSO TREATED AND UNDERWENT POLYETHYLENE GLYCOL (PEG) TESTING. THE E602 MODULE SERIAL NUMBER WAS (B)(4). THE E411 ANALYZER SERIAL NUMBER WAS (B)(4). THE E801 MODULE SERIAL NUMBER USED AT THE INVESTIGATION SITE WAS (B)(4). THE TSH REAGENT LO

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 7890837 ↗
• MalfunctionSep 6, 2018High Test Results; High Test Results

  THE CUSTOMER PROVIDED DATA FOR A TOTAL OF 8 SAMPLES FROM 8 DIFFERENT PATIENTS TESTED FOR MULTIPLE THYROID ASSAYS ON THE COBAS 8000 E 801 MODULE . OF THESE SAMPLES, FIVE HAD ERRONEOUS RESULTS FOR THE ELECSYS TSH ASSAY. IT WAS ASKED, BUT IT IS NOT KNOWN IF ANY ERRONEOUS RESULTS WERE REPORTED OUTSIDE OF THE LABORATORY. REFER TO THE ATTACHMENT FOR ALL PATIENT DATA. ALL HIGHLIGHTED VALUES ARE ERRONEOUS. THE SAMPLES WERE INITIALLY TESTED ON THE CUSTOMER'S E 801 ANALYZER. THE SAMPLES WERE PROVIDED FOR INVESTIGATION, WHERE THEY WERE TESTED ON A SECOND E 801 ANALYZER, A COBAS 8000 E 602 MODULE, AND A COBAS E 411 IMMUNOASSAY ANALYZER. THE SAMPLES WERE ALSO TESTED ON A CENTAUR ANALYZER. IN ADDITION, THE SAMPLES WERE TREATED WITH POLYETHYLENE GLYCOL (PEG) AND TESTED ON A ROCHE ELECSYS ANALYZER. NO ADVERSE EVENTS WERE ALLEGED TO HAVE OCCURRED WITH THE PATIENTS. THE SERIAL NUMBER OF THE E 801 ANALYZER USED AT THE CUSTOMER SITE WAS ASKED FOR, BUT NOT PROVIDED. THE SERIAL NUMBER OF THE E 801 ANALYZER USED FOR INVESTIGATION WAS (B)(6). TSH REAGENT LOT NUMBER 331814, WITH AN EXPIRATION DATE OF 31-AUG-2019 WAS USED ON THIS ANALYZER. THE SERIAL NUMBER OF THE E 602 ANALYZER USED FOR INVESTIGATION WAS (

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 7850272 ↗
• MalfunctionAug 27, 2018High Test Results; High Test Results

  THE CUSTOMER PROVIDED DATA FOR A TOTAL OF 8 PATIENT SAMPLES TESTED FOR MULTIPLE THYROID ASSAYS ON THE COBAS 8000 E 801 MODULE . OF THESE SAMPLES, THREE HAD ERRONEOUS RESULTS FOR THE ELECSYS TSH ASSAY. IT WAS ASKED, BUT IT IS NOT KNOWN IF ANY ERRONEOUS RESULTS WERE REPORTED OUTSIDE OF THE LABORATORY. THE SAMPLES WERE INITIALLY TESTED ON THE CUSTOMER'S E 801 ANALYZER. THE SAMPLES WERE PROVIDED FOR INVESTIGATION, WHERE THEY WERE TESTED ON A SECOND E 801 ANALYZER, A COBAS 8000 E 602 MODULE, AND A COBAS E 411 IMMUNOASSAY ANALYZER. THE SAMPLES WERE ALSO TESTED ON A CENTAUR ANALYZER. IN ADDITION, THE SAMPLES WERE TREATED WITH POLYETHYLENE GLYCOL (PEG) AND TESTED ON A ROCHE ELECSYS ANALYZER. NO ADVERSE EVENTS WERE ALLEGED TO HAVE OCCURRED WITH THE PATIENT. THE SERIAL NUMBER OF THE E 801 ANALYZER USED AT THE CUSTOMER SITE WAS ASKED FOR, BUT NOT PROVIDED. THE SERIAL NUMBER OF THE E 801 ANALYZER USED FOR INVESTIGATION WAS (B)(4). TSH REAGENT LOT NUMBER 331814, WITH AN EXPIRATION DATE OF 31-AUG-2019 WAS USED ON THIS ANALYZER. THE SERIAL NUMBER OF THE E 602 ANALYZER USED FOR INVESTIGATION WAS (B)(4). TSH REAGENT LOT NUMBER 328081, WITH AN EXPIRATION DATE OF 31-DEC-2018 WAS USED ON THIS ANALYZER

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 7818128 ↗
• MalfunctionAug 23, 2018High Test Results; High Test Results

  THE CUSTOMER COMPLAINED OF DISCREPANT HIGH RESULTS FOR 1 PATIENT SAMPLE TESTED FOR ELECSYS TSH ON A COBAS E 801 MODULE. THE PATIENT WAS TESTED ON THE E801 MODULE AND THE TSH RESULT WAS 5.11 UIU/ML AND WAS REPORTED OUTSIDE OF THE LABORATORY. THE RESULT WAS QUESTIONED BY THE DOCTOR AS THE PATIENT IS TAKING L-THYROXINE AND REPEAT TESTING BY ANOTHER METHOD WAS REQUESTED. ON (B)(6) 2018, THE SAMPLE WAS SENT TO AN EXTERNAL LABORATORY USING AN UNKNOWN METHOD AND THE TSH RESULT WAS < 0.01 MIU/ML. THIS RESULT WAS WHAT THE DOCTOR EXPECTED FOR THIS PATIENT. THERE WAS NO ALLEGATION THAT AN ADVERSE EVENT OCCURRED. THE 801 MODULE SERIAL NUMBER WAS (B)(4).

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 7808776 ↗
• MalfunctionAug 17, 2018High Test Results; High Test Results

  THE CUSTOMER QUESTIONED THYROID RESULTS FOR 1 PATIENT SAMPLE TESTED ON A COBAS E 801 MODULE. THE SAMPLE WAS SUBMITTED FOR INVESTIGATION WHERE DISCREPANT RESULTS WERE IDENTIFIED FOR ELECSYS TSH BETWEEN THE CUSTOMER'S E801 MODULE AND THE SIEMENS CENTAUR METHOD. REFER TO ATTACHED DATA FOR THE PATIENT RESULTS. THE INITIAL RESULTS FROM THE CUSTOMER SITE WERE REPORTED OUTSIDE OF THE LABORATORY. THERE WAS NO ALLEGATION THAT AN ADVERSE EVENT OCCURRED. THE CUSTOMER'S E801 MODULE SERIAL NUMBER WAS (B)(4). THE E801 MODULE USED AT THE INVESTIGATION SITE WAS (B)(4). THE TSH REAGENT LOT NUMBER USED AT THE INVESTIGATION SITE WAS 283556 WITH AN EXPIRATION DATE OF FEB-2019. CALIBRATION AND QC DATA FROM THE CUSTOMER SITE WAS NOT PROVIDED. FROM THE DATA PROVIDED, A GENERAL REAGENT ISSUE CAN BE EXCLUDED. ASSAYS FROM DIFFERENT MANUFACTURERS, IN THIS CASE SIEMENS CAN GENERATE DIFFERENT RESULTS DUE TO THE OVERALL SETUPS OF THE ASSAYS, THE ANTIBODIES USED, AND DIFFERENCES IN REFERENCE MATERIALS AND THE STANDARDIZATION METHODOLOGY USED. THE INVESTIGATION WAS UNABLE TO FIND A DEFINITIVE ROOT CAUSE.

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 7794394 ↗
• MalfunctionAug 16, 2018Low Test Results; Low Test Results

  THE CUSTOMER COMPLAINED OF QUESTIONABLE ELECSYS TSH ASSAY RESULTS FOR 10 PATIENT SAMPLES TESTED ON A COBAS 8000 E 801 MODULE. IT WAS UNKNOWN IF THE ERRONEOUS RESULTS WERE RELEASED OUTSIDE OF THE LABORATORY. THERE WAS NO ALLEGATION OF AN ADVERSE EVENT. THE COBAS E801 SERIAL NUMBER WAS (B)(4). REVIEW OF THE ANALYZER ALARM HISTORY DID NOT GIVE ANY INDICATION OF AN ISSUE. THE CUSTOMER WAS USING RACK ADAPTERS. THE FIELD ENGINEERING SPECIALIST INSPECTED THE ANALYZER AND DID NOT FIND ANY PROBLEMS. THE DISCREPANT RESULTS STARTED TO OCCUR WHEN THE CUSTOMER SWITCHED TO A NEW PACK OF REAGENT. BASED ON THE INFORMATION PROVIDED A DEFINITIVE ROOT CAUSE COULD NOT BE DETERMINED.

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 7790081 ↗
• MalfunctionAug 15, 2018High Test Results; High Test Results

  THE CUSTOMER COMPLAINED OF A QUESTIONABLE ELECSYS TSH ASSAY RESULT AND A QUESTIONABLE ELECSYS FT4 II ASSAY RESULT FOR 1 PATIENT SAMPLE TESTED ON A COBAS 8000 E 801 MODULE COMPARED TO THE RESULTS FROM AN ARCHITECT ANALYZER AND A SIEMENS CENTAUR ANALYZER. THIS MEDWATCH WILL COVER TSH. REFER TO MEDWATCH WITH PATIENT IDENTIFIER (B)(6) FOR INFORMATION ON THE FT4 II RESULTS. PLEASE REFER TO THE ATTACHMENT FOR PATIENT DATA. THE ERRONEOUS RESULTS WERE REPORTED OUTSIDE OF THE LABORATORY. THERE WAS NO ALLEGATION OF AN ADVERSE EVENT. THE CUSTOMER'S COBAS E801 SERIAL NUMBER WAS NOT PROVIDED. THE COBAS E801 SERIAL NUMBER USED AT THE INVESTIGATION SITE WAS (B)(4). THE TSH REAGENT LOT NUMBER USED AT THE INVESTIGATION SITE WAS 283556 WITH AN EXPIRATION DATE OF FEB-2019. THE INVESTIGATION IS CURRENTLY ONGOING.

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 7785802 ↗
• MalfunctionJul 30, 2018Low Test Results; Low Test Results

  THE CUSTOMER STATED THAT THEY RECEIVED AN ERRONEOUS RESULT FOR ONE PATIENT SAMPLE TESTED WITH THE ELECSYS TSH ASSAY ON A COBAS 8000 E 801 MODULE (E801). THE ERRONEOUS RESULT WAS REPORTED OUTSIDE OF THE LABORATORY. THE CUSTOMER SUSPECTED THAT THERE WERE FALSE HIGH THYROID RESULTS FOR THE SAMPLE. THE SAMPLE WAS INITIALLY TESTED ON THE CUSTOMER'S E801 ANALYZER. THE SAMPLE WAS REPEATED ON A CENTAUR ANALYZER. THE SAMPLE WAS ALSO PROVIDED FOR INVESTIGATION, WHERE IT WAS TESTED ON A SECOND E801 ANALYZER. NO ADVERSE EVENTS WERE ALLEGED TO HAVE OCCURRED WITH THE PATIENT. THE SERIAL NUMBER OF THE E801 ANALYZER USED AT THE CUSTOMER SITE WAS (B)(4). THE SERIAL NUMBER OF THE E801 ANALYZER USED FOR INVESTIGATION WAS (B)(4). TSH REAGENT LOT NUMBER 283556, WITH AN EXPIRATION DATE OF FEBRUARY 2019 WAS USED ON THIS ANALYZER. BASED ON THE INFORMATION PROVIDED, A GENERAL REAGENT ISSUE CAN MOST LIKELY BE EXCLUDED. ASSAYS FROM DIFFERENT VENDORS CAN GENERATE DIFFERENT VALUES. THIS RELATES TO THE OVERALL SETUPS OF THE ASSAYS, THE ANTIBODIES USED, DIFFERENCES IN REFERENCE MATERIALS/METHODS, AND DIFFERENCES IN THE STANDARDIZATION METHODOLOGY USED. THE INVESTIGATION WAS UNABLE TO FIND A DEFINITIVE ROOT CAUSE

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 7730897 ↗
• MalfunctionJul 25, 2018Non Reproducible Results; Non Reproducible Results

  THE CUSTOMER QUESTIONED THYROID RESULTS FOR 6 PATIENT SAMPLES TESTED FOR ELECSYS FT3 III (FT3 III), ELECSYS TSH (TSH) AND ELECSYS FT4 III (FT4 III) ON A COBAS E 801 MODULE. THE 6 PATIENT SAMPLES WERE SUBMITTED FOR INVESTIGATION WHERE DISCREPANT RESULTS WERE IDENTIFIED FOR FT3 III, TSH AND FT4 III BETWEEN THE CUSTOMER'S E801 MODULE, THE CENTAUR METHOD, AN E801 MODULE USED AT THE INVESTIGATION SITE, A COBAS 8000 E 602 MODULE USED AT THE INVESTIGATION SITE AND A COBAS E 411 IMMUNOASSAY ANALYZER USED AT THE INVESTIGATION SITE. IT IS NOT KNOWN IF ANY INCORRECT RESULTS WERE REPORTED OUTSIDE OF THE LABORATORY. THIS MEDWATCH WILL COVER TSH. REFER TO MEDWATCH WITH (B)(6) FOR INFORMATION ON THE FT4 III ERRONEOUS RESULTS AND MEDWATCH WITH (B)(6) FOR INFORMATION ON THE FT3 III ERRONEOUS RESULTS. REFER TO ATTACHED DATA TITLED "PATIENT RESULTS" FOR THE PATIENT RESULTS. THERE WAS NO ALLEGATION THAT AN ADVERSE EVENT OCCURRED. THE SERIAL NUMBER FOR THE CUSTOMER'S E801 MODULE WAS NOT PROVIDED. THE PATIENT SAMPLES WERE ALSO TREATED AND UNDERWENT POLYETHYLENE GLYCOL (PEG) TESTING. REFER TO ATTACHED DATA TITLED "PEG TESTING" FOR THESE RESULTS. THE E602 MODULE SERIAL (B)(4). THE E411 ANALYZER SERIAL (B)

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 7719585 ↗
• MalfunctionJul 19, 2018Low Test Results; Low Test Results

  THE CUSTOMER COMPLAINED OF QUESTIONABLE THYROID RESULTS FOR 2 PATIENT SAMPLES TESTED ON A COBAS 8000 E 801 MODULE AND A COBAS 8000 E 601 COMPARED TO A SIEMENS CENTAUR. FROM THE DATA PROVIDED, A REPORTABLE MALFUNCTION WAS PROVIDED FOR ELECSYS TSH ASSAY (TSH), ELECSYS T3 (T3), ELECSYS T4 ASSAY (T4), AND ELECSYS FT4 II ASSAY (FT4 II). MEDWATCHES RELATED TO THIS ISSUE INCLUDED PATIENT IDENTIFIERS (B)(6). PLEASE REFER TO THE ATTACHMENT TO THIS MEDWATCH FOR PATIENT DATA. THE ERRONEOUS RESULTS WERE NOT RELEASED OUTSIDE OF THE LABORATORY. THERE WAS NO ALLEGATION OF AN ADVERSE EVENT. THE COBAS E801 SERIAL NUMBER WAS (B)(4). THE COBAS E601 SERIAL NUMBER WAS REQUESTED BUT WAS NOT PROVIDED. THE INVESTIGATION IS CURRENTLY ONGOING.

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 7702337 ↗
• MalfunctionJul 16, 2018Non Reproducible Results; Non Reproducible Results

  THE CUSTOMER COMPLAINED OF QUESTIONABLE ELECSYS TSH ASSAY, ELECSYS FT4 II ASSAY, AND ELECSYS FT3 III RESULTS FOR FIVE SEPARATE SAMPLES FROM 1 PATIENT THAT WERE NOT MATCHING THE PATIENT'S CLINICAL PICTURE. THE TESTING WAS PERFORMED ON A COBAS 8000 E 801 MODULE WITH A SERIAL (B)(4). MEDWATCHES RELATED TO THIS ISSUE HAVE (B)(6). THE CUSTOMER STATED THAT THE PATIENT DOES NOT HAVE ANY "THYROID SYMPTOMS" AND THAT THEY SUSPECT THAT THERE IS AN INTERFERENCE. THE QUESTIONABLE RESULTS WERE REPORTED OUTSIDE OF THE LABORATORY. THERE WAS NO ALLEGATION OF AN ADVERSE EVENT. THE INVESTIGATION IS CURRENTLY ONGOING.

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 7690204 ↗
• MalfunctionJul 12, 2018Non Reproducible Results; Non Reproducible Results

  THE CUSTOMER QUESTIONED THYROID RESULTS FOR 6 PATIENT SAMPLES TESTED FOR ELECSYS FT4 II (FT4 II), ELECSYS FT3 III (FT3 III) AND ELECSYS TSH (TSH) ON A COBAS E 801 MODULE. THE 6 PATIENT SAMPLES WERE SUBMITTED FOR INVESTIGATION WHERE DISCREPANT RESULTS WERE IDENTIFIED FOR FT4 II, FT3 III AND TSH BETWEEN THE CUSTOMER'S E801 MODULE, THE CENTAUR METHOD, AN E801 MODULE USED AT THE INVESTIGATION SITE, A COBAS 8000 E 602 MODULE USED AT THE INVESTIGATION SITE AND A COBAS E 411 IMMUNOASSAY ANALYZER USED AT THE INVESTIGATION SITE. IT IS NOT KNOWN IF ANY INCORRECT RESULTS WERE REPORTED OUTSIDE OF THE LABORATORY. THIS MEDWATCH WILL COVER TSH. REFER TO MEDWATCH WITH PATIENT IDENTIFIER (B)(6) FOR INFORMATION ON THE FT4 II ERRONEOUS RESULTS AND MEDWATCH WITH PATIENT IDENTIFIER (B)(6) FOR INFORMATION ON THE FT3 III ERRONEOUS RESULTS. REFER TO ATTACHED DATA TITLED "PATIENT RESULTS" FOR THE PATIENT RESULTS. THERE WAS NO ALLEGATION THAT AN ADVERSE EVENT OCCURRED. THE SERIAL NUMBER FOR THE CUSTOMER'S E801 MODULE WAS NOT PROVIDED. THE PATIENT SAMPLES WERE ALSO TREATED AND UNDERWENT POLYETHYLENE GLYCOL (PEG) TESTING. REFER TO ATTACHED DATA TITLED "PEG TESTING" FOR THESE RESULTS. THE E602 MODULE SERIAL NU

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 7680856 ↗

Recalls under the same FDA submission

These recalls involve devices cleared under K162606. One submission often covers many models, so check the product and lot details in each record.

• Z-0044-2020 · Aug 13, 2019 · Terminated
  AssayTip/AssayCup Tray-used on the cobas e 801 module which is a part of the cobas c 8000 MODULAR Analyzer Series (IVD for in vitro determination of analytes in human body fluids)
• Z-1249-2019 · Mar 15, 2019 · Terminated
  cobas e 801 immunoassay analyzer
• Z-2136-2018 · Apr 3, 2018 · Terminated
  cobas e 801 immunoassay analyzer, cobas 8000 Modular Series The device is a fully automated, software controlled analyzer system for in vitro determination of analytes in human bo