Elecsys Anti-CCP 07251670190Recalls & reported problems

Summary

The FDA's MAUDE database contains 8 adverse event reports that list this exact device (DI 04015630940370), received between Mar 7, 2023 and Oct 27, 2025 — classified as 8 malfunctions.

The most frequently reported specific device problem is “High Test Results” (5 reports).

2 other recalls cover devices cleared under the same FDA submission (K081338); 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 8 most recent of 8 reports, in the reporter's own words as published by the FDA.

• MalfunctionOct 27, 2025Incorrect Measurement; Incorrect Measurement

  WE RECEIVED AN ALLEGATION OF QUESTIONABLE HIGH RESULTS NOT CORRESPONDING TO THE CLINICAL PICTURE FOR 1 PATIENT TESTED FOR ELECSYS ANTI-CCP (ANTI-CCP) ON A COBAS E 801 ANALYTICAL UNIT. ON (B)(6) 2025, THE RESULT FROM THE E801 ANALYZER WAS 217 U/ML. THIS SAMPLE WAS SENT TO AN EXTERNAL LABORATORY USING THE THERMO FISHER METHOD, AND THE RESULT WAS "IN THE REFERENCE RANGE." THE SPECIFIC RESULT WAS NOT PROVIDED. ON (B)(6) 2025, A NEW SAMPLE WAS OBTAINED, AND THE RESULT FROM THE E801 ANALYZER WAS 235 U/ML. ON (B)(6) 2025, THE REPEAT RESULT FROM THE E801 ANALYZER WAS 236 U/ML. THIS SAMPLE WAS SENT TO AN EXTERNAL LABORATORY USING THE THERMO FISHER METHOD, AND THE RESULT WAS 1 U/ML (REFERENCE RANGE 0 ¿ 10 U/ML).

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 23390835 ↗
• MalfunctionOct 25, 2024False Positive Result; False Positive Result

  THE INITIAL REPORTER STATED THEY RECEIVED QUESTIONABLE RESULTS FOR THREE SAMPLES COLLECTED FROM THE SAME PATIENT TESTED WITH ELECSYS ANTI-CCP ON A COBAS E 801 MODULE. THE RESULTS DID NOT AGREE WITH THE CLINICAL BACKGROUND OF THE PATIENT IN QUESTION. THE FIRST SAMPLE COLLECTED FROM THE PATIENT RESULTED IN AN ANTI-CCP VALUE OF > 500 U/ML. THE SECOND SAMPLE COLLECTED FROM THE PATIENT RESULTED IN AN ANTI-CCP VALUE OF 443 U/ML ON (B)(6) 2024. THIS SAMPLE HAD A NEGATIVE ANTI-CCP RESULT WHEN TESTED ON THE PHADIA PLATFORM AT ANOTHER SITE. THE THIRD SAMPLE COLLECTED FROM THE PATIENT WAS INITIALLY TESTED AT ANOTHER SITE ON THE PHADIA PLATFORM, RESULTING IN A NEGATIVE ANTI-CCP RESULT. THIS SAMPLE WAS THEN DILUTED TO RULE OUT ANY PROZONE EFFECT AND THE RESULT REMAINED NEGATIVE ON THE PHADIA PLATFORM. THE SAMPLE WAS THEN SENT TO THE CUSTOMER SITE WHERE IT WAS TESTED ON THE E801 ANALYZER, RESULTING IN AN ANTI-CCP VALUE OF 481 U/ML. THE 481 U/ML IS CONSIDERED A STRONG POSITIVE BY THE CUSTOMER.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 20532970 ↗
• MalfunctionAug 7, 2024High Test Results; High Test Results

  THE INITIAL REPORTER STATED THEY RECEIVED QUESTIONABLE RESULTS FOR 8 SAMPLES FROM THE SAME PATIENT TESTED WITH ELECSYS ANTI-CCP ON A COBAS E 801 ANALYTICAL UNIT. THE EIGHTH SAMPLE WAS ALSO TESTED ON A SECOND E 801 UNIT. THE ELECSYS ANTI-CCP RESULTS WERE ALL HIGH (REFERENCE RANGE = < 17 U/ML), BUT THE PATIENT HAD NO CLINICAL SYMPTOMS. THE FIRST SAMPLE RESULTED IN AN ANTI-CCP VALUE OF 108 U/ML. THE SECOND SAMPLE RESULTED IN AN ANTI-CCP VALUE OF 193 U/ML ON (B)(6) 2022. THE THIRD SAMPLE RESULTED IN AN ANTI-CCP VALUE OF 216 U/ML ON (B)(6) 2022. THE FOURTH SAMPLE RESULTED IN AN ANTI-CCP VALUE OF 185 U/ML ON (B)(6) 2023. THE FIFTH SAMPLE RESULTED IN AN ANTI-CCP VALUE OF 184 U/ML ON (B)(6) 2023. THE SIXTH SAMPLE RESULTED IN AN ANTI-CCP VALUE OF 172 U/ML ON (B)(6) 2023. THE SEVENTH SAMPLE RESULTED IN AN ANTI-CCP VALUE OF 184 U/ML ON (B)(6) 2023. THE EIGHTH SAMPLE INITIALLY RESULTED IN AN ANTI-CCP VALUE OF 162 U/ML ON (B)(6) 2024. THIS SAMPLE WAS REPEATED ON THE SAME E 801 SYSTEM, RESULTING IN A VALUE OF 184 U/ML. IT WAS ALSO REPEATED ON A SECOND E 801 ANALYZER, RESULTING IN A VALUE OF 187 U/ML. THE PATIENT WAS TESTED AT THREE OTHER HOSPITALS USING THE EUROIMMUN ANTI-CCP METHOD AND TWO UNKN

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 19927573 ↗
• MalfunctionJan 19, 2024High Test Results; High Test Results

  THE INITIAL REPORTER RECEIVED A QUESTIONABLE ELECSYS ANTI-CCP (ANTI-CCP) RESULT FROM ONE PATIENT SAMPLE TESTED ON THE COBAS E 801 ANALYTICAL UNIT. THE RESULT WAS 169 U/ML. THE REPORTER STATED THIS RESULT WAS DISCREPANT WITH THE CLINICAL EXPECTATION (BELOW 17 U/ML) AND THE ANTI-CCP IGG ENZYME-LINKED IMMUNOSORBENT ASSAY (ELISA) RESULT. THE REPORTER POSTULATES A POSSIBLE INTERFERENCE WITH ANTI-STREPTAVIDIN ANTIBODIES.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 18542103 ↗
• MalfunctionOct 9, 2023High Test Results; High Test Results

  THE INITIAL REPORTER COMPLAINED OF A DISCREPANT HIGH RESULT FOR 1 PATIENT SAMPLE TESTED FOR ELECSYS ANTI-CCP (ANTI-CCP) ON A COBAS E 801 ANALYTICAL UNIT COMPARED TO A COMPETITOR METHOD. THE INITIAL RESULT FROM THE E801 ANALYZER WAS > 500 U/ML. THE SAMPLE WAS REPEATED BY A COMPETITOR METHOD (IMMUNOCAP 250) AND THE RESULT WAS 0.2 MOC (REFERENCE RANGE <1.0). ON (B)(6) 2023 THE CUSTOMER REPEATED THE ORIGINAL PATIENT SAMPLE FOR CONFIRMATION ON THE E801 ANALYZER AND THE RESULT WAS > 500 U/ML.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 17896496 ↗
• MalfunctionJul 6, 2023High Test Results; High Test Results

  THE INITIAL REPORTER STATED THEY RECEIVED QUESTIONABLE RESULTS FOR SAMPLES FROM ONE PATIENT TESTED WITH THE ELECSYS ANTI-CCP ASSAY ON A COBAS E 801 ANALYTICAL UNIT (SERIAL NUMBER (B)(6)) AND COMPARED TO THE SIEMENS METHOD. AN INTERFERENCE IS SUSPECTED BY THE CUSTOMER. ON (B)(6)2023, A SAMPLE FROM THE PATIENT WAS TESTED USING THE ELECSYS ANTI-CCP ASSAY, RESULTING IN A VALUE OF 309 U/ML. ON (B)(6) 2023, A SAMPLE FROM THE PATIENT WAS TESTED USING THE ELECSYS ANTI-CCP ASSAY, RESULTING IN A VALUE OF 249 U/ML. ON (B)(6) 2023, A SAMPLE FROM THE PATIENT WAS TESTED USING THE SIEMENS ANTI-CCP METHOD, RESULTING IN A VALUE OF <0.5 KU/L. THIS RESULT IS CONSISTENT WITH THE PATIENT¿S CLINICAL PICTURE.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 17273355 ↗
• MalfunctionJun 16, 2023Low Test Results; Non Reproducible Results; Low Test Results; Non Reproducible Results

  THE INITIAL REPORTER COMPLAINED OF A DISCREPANT LOW RESULT FOR 1 PATIENT SAMPLE TESTED FOR ELECSYS ANTI-CCP (ANTI-CCP) ON A COBAS E 801 ANALYTICAL UNIT. THE INITIAL RESULT WAS 14.4 U/ML. THIS RESULT WAS REPORTED OUTSIDE OF THE LABORATORY WHERE IT WAS QUESTIONED BY THE PATIENT. ON (B)(6) 2023 THE SAMPLE WAS REPEATED WITH RESULTS OF 23.6 U/ML, 21 U/ML, AND 20.8 U/ML. ON (B)(6) 2023 THE SAMPLE WAS REPEATED IN THE MORNING WITH A RESULT OF 30.2 U/ML. THE SAMPLE WAS REPEATED LATER THAT AFTERNOON WITH A RESULT OF 23.7 U/ML. ALL OF THE REPEAT RESULTS WERE MORE CONSISTENT WITH THE PATIENT¿S CLINICAL CONDITION.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 17145818 ↗
• MalfunctionMar 7, 2023Incorrect, Inadequate or Imprecise Result or Readings; High Test Results; Incorrect, Inadequate or Imprecise Result or Readings; High Test Results

  THE INITIAL REPORTER STATED THEY RECEIVED DISCREPANT RESULTS FOR TWO SAMPLES COLLECTED FROM ONE PATIENT AND TESTED WITH ELECSYS ANTI-CCP ON A COBAS 6000 E 601 MODULE (SERIAL NUMBER (B)(4) AND A COBAS E 801 ANALYTICAL UNIT (SERIAL NUMBER (B)(4). THE SAMPLE RESULTS WERE REPORTED OUTSIDE OF THE LABORATORY TO THE PATIENT. WHEN THE FIRST SAMPLE WAS TESTED ON THE E 801 ANALYZER, IT RESULTED IN AN ANTI-CCP VALUE OF 41.1 U/ML ON (B)(6) 2023. THIS SAMPLE WAS REPEATED ON THE E 601 ANALYZER ON (B)(6) 2023, RESULTING IN A VALUE OF < 7.00 U/ML WITH A DATA FLAG. THE SECOND SAMPLE HAD SIMILAR RESULTS. ON (B)(6) 2023, THE SECOND SAMPLE RESULTED IN AN ANTI-CCP VALUE OF 38.0 U/ML WHEN TESTED ON THE E 801 ANALYZER. THIS SAMPLE RESULTED IN A VALUE OF < 7.00 U/ML WHEN TESTED ON THE E 601 ANALYZER. ANTI-CCP REAGENT LOT 66022801 (EXPIRATION DATE = 30-SEP-2023) WAS USED ON THE E 801 ANALYZER. ANTI-CCP REAGENT LOT 637426 WAS USED ON THE E 601 ANALYZER. THIS REAGENT EXPIRATION DATE WAS REQUESTED, BUT NOT PROVIDED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 16498612 ↗

Recalls under the same FDA submission

These recalls involve devices cleared under K081338. One submission often covers many models, so check the product and lot details in each record.

• Z-2361-2019 · Jul 16, 2019 · Terminated
  Roche Elecsys Anti-CCP Immunoassay Catalog # 07251670190
• Z-2362-2019 · Jul 16, 2019 · Terminated
  Roche Elecsys Anti-CCP Immunoassay Catalog # 05031656160