cobas 8000 c 502 Module 5964067001Recalls & reported problems

Summary

The FDA's MAUDE database contains 403 adverse event reports that list this exact device (DI 04015630928354), received between Jul 12, 2018 and Sep 24, 2026 — classified as 403 malfunctions.

The most frequently reported specific device problem is “High Test Results” (156 reports).

11 other recalls cover devices cleared under the same FDA submission (K100853); 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 403 reports, in the reporter's own words as published by the FDA.

• MalfunctionSep 24, 2026High Test Results

  We received an allegation about discrepant results for 1 patient sample tested with Glucose HK Gen.3 assay on a cobas 8000 cobas c 502 module.Initial result: 205 mg/dL.Multiple abnormal aspiration alarms prompted a repeat of the sample. No questionable result was reported outside the laboratory.Repeat result: 104 mg/dL.The repeat result was reported outside the laboratory.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 50885933 ↗
• MalfunctionSep 11, 2026False Positive Result

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 50737227 ↗
• MalfunctionSep 10, 2026Incorrect, Inadequate or Imprecise Result or Readings

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 50720501 ↗
• MalfunctionAug 10, 2026Mechanical Jam; Non Reproducible Results

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 50192658 ↗
• MalfunctionAug 3, 2026Non Reproducible Results

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 50121981 ↗
• MalfunctionJul 27, 2026Incorrect, Inadequate or Imprecise Result or Readings; Low Test Results

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 50005683 ↗
• MalfunctionJun 17, 2026Incorrect, Inadequate or Imprecise Result or Readings

  THE INITIAL REPORTER QUESTIONED THE RESULTS FOR MULTIPLE PATIENT SAMPLES AND MULTIPLE ASSAYS ON A COBAS 8000 COBAS C 502 MODULE. DISCREPANT RESULTS WERE PROVIDED FOR 3 PATIENT SAMPLES TESTED FOR GLUCOSE HK GEN.3 (GLUC3) AND CALCIUM GEN.2 (CA2). SAMPLE 1 INITIAL CA2 RESULT WAS 5.3 MG/DL WITH A DATA FLAG. THE REPEAT RESULT WAS 9.3 MG/DL. "SAMPLE 4" INITIAL GLUC3 RESULT WAS 17 MG/DL. THE REPEAT RESULT WAS 111 MG/DL. "SAMPLE 5" INITIAL GLUC3 RESULT WAS 40 MG/DL. THE REPEAT RESULT WAS 91 MG/DL.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 25531346 ↗
• MalfunctionMay 26, 2026Non Reproducible Results

  THE INITIAL REPORTER STATED THEY RECEIVED QUESTIONABLE CALCIUM GEN.2 AND TOTAL PROTEIN GEN.2 ASSAY RESULTS FOR ONE PATIENT'S SAMPLE TESTED ON THE COBAS 8000 COBAS C 502 MODULE. CALCIUM GEN.2 THE INITIAL RESULT WAS 7.7 MG/DL WITH A DATA FLAG. THE REPEAT RESULT WAS 9.7 MG/DL. TOTAL PROTEIN GEN.2 THE INITIAL RESULT WAS 4.9 G/DL WITH A DATA FLAG. THE REPEAT RESULT WAS 7.2 G/DL. THE INITIAL RESULTS WERE DEEMED LOW AND WERE QUESTIONED BY THE DOCTOR, PROMPTING THE RERUN.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 25275077 ↗
• MalfunctionMay 19, 2026Non Reproducible Results

  THERE WAS AN ALLEGATION OF QUESTIONABLE AMMONIA II RESULTS FOR 1 PATIENT SAMPLE ON A COBAS 8000 COBAS C 502 MODULE. THE INITIAL RESULT WAS 281.4 UG/DL, AND THE REPEATED RESULT WAS 57.4 UG/DL. THE SAMPLE WAS REPEATED BECAUSE THE CUSTOMER'S QC RESULTS WERE ABNORMALLY HIGH.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 25215565 ↗
• MalfunctionMay 12, 2026Incorrect, Inadequate or Imprecise Result or Readings; High Test Results

  THE INITIAL REPORTER RECEIVED QUESTIONABLE CREATININE JAFFÉ GEN. 2 ASSAY RESULTS FROM MULTIPLE PATIENT SAMPLES TESTED ON THE COBAS 8000 COBAS C 502 MODULE. ONE EXAMPLE WITH DISCREPANT RESULTS WAS PROVIDED: THE INITIAL RESULT WAS 2.85 MG/DL. THE REPEAT RESULT WAS 2.00 MG/DL. THE DOCTOR QUESTIONED THE HIGH INITIAL RESULT, PROMPTING THE RERUN. THE REPEAT RESULT WAS DEEMED CORRECT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 25147041 ↗
• MalfunctionMay 6, 2026Non Reproducible Results

  THE INITIAL REPORTER STATED THEY RECEIVED DISCREPANT RESULTS FOR TWO PATIENT SAMPLES TESTED WITH TINA-QUANT HEMOGLOBIN A1C GEN.3 - HEMOLYSATE AND WHOLE BLOOD APPLICATION ON A COBAS 8000 C 502 MODULE. THE INITIAL SAMPLE RESULTS WERE QUESTIONED BY MEDICAL STAFF. THE SAMPLES WERE REPEATED AND THE REPEAT RESULTS WERE DEEMED CORRECT. THE FIRST SAMPLE INITIALLY RESULTED IN AN HBA1C VALUE OF 6.7 % AND IT REPEATED AS 5.2 %. THE SECOND SAMPLE INITIALLY RESULTED IN AN HBA1C VALUE OF 6.5 % AND IT REPEATED AS 5.1 %.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 25092580 ↗
• MalfunctionApr 30, 2026High Test Results

  THE INITIAL REPORTER RECEIVED QUESTIONABLE TINA-QUANT HEMOGLOBIN A1C GEN.3 - HEMOLYSATE AND WHOLE BLOOD APPLICATION ASSAY RESULTS FROM THREE PATIENT SAMPLES TESTED ON THE COBAS 8000 COBAS C 502 MODULE. PATIENT SAMPLE 1 THE INITIAL RESULT FROM THE MODULE WAS 11.0%. THE REPEAT RESULT FROM ANOTHER ANALYZER WAS 6.3%. THE DOCTOR QUESTIONED THE RESULT, PROMPTING THE RERUN. THE REPEAT RESULT WAS DEEMED CORRECT. PATIENT SAMPLE 2 THE INITIAL RESULT FROM THE MODULE WAS 16.4%. THE REPEAT RESULT FROM ANOTHER ANALYZER WAS 5.15%. PATIENT SAMPLE 3 THE INITIAL RESULT FROM THE MODULE WAS 10.1%. THE REPEAT RESULT FROM ANOTHER ANALYZER WAS 5.07%.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 25049688 ↗
• MalfunctionApr 27, 2026Low Test Results

  WE RECEIVED AN ALLEGATION ABOUT DISCREPANT RESULTS FOR 1 PATIENT SAMPLE TESTED WITH CALCIUM GEN.2 ASSAY ON A COBAS 8000 COBAS C 502 MODULE. THE INITIAL RESULT WAS 6.7 MG/DL. THE PATIENT WAS TESTED FOR CALCIUM AT THE EMERGENCY DEPARTMENT AND RECEIVED A "NORMAL" CALCIUM RESULT, PROMPTING THE PHYSICIAN TO REQUEST A REPEAT OF THE ORIGINAL SAMPLE. THE ORIGINAL SAMPLE WAS REPEATED TWICE ON A DIFFERENT COBAS C 502 MODULE, AND THE REPEAT RESULTS WERE 9.37 MG/DL AND 9.57 MG/DL. THE REPEAT RESULTS WERE DEEMED TO BE CORRECT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 25001610 ↗
• MalfunctionApr 17, 2026Incorrect, Inadequate or Imprecise Result or Readings; Low Test Results

  THE INITIAL REPORTER RECEIVED QUESTIONABLE TINA-QUANT IGG GEN.2 ASSAY RESULTS FROM THREE PATIENT SAMPLES TESTED ON THE COBAS 8000 COBAS C 502 MODULE. PATIENT SAMPLE 1 THE INITIAL RESULT WAS 587 MG/DL. THE REPEAT RESULT WAS 1200 MG/DL. PATIENT SAMPLE 2 THE INITIAL RESULT WAS 713 MG/DL. THE REPEAT RESULT WAS 1351 MG/DL. PATIENT SAMPLE 3 THE INITIAL RESULT WAS 1 MG/DL. THE REPEAT RESULT WAS 1613 MG/DL. THE INITIAL RESULTS WERE DEEMED LOW, PROMPTING THE RERUN. THE REPEAT RESULTS WERE DEEMED CORRECT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 24915851 ↗
• MalfunctionApr 16, 2026Low Test Results

  THERE WAS AN ALLEGATION OF QUESTIONABLE TINA-QUANT IGG GEN2 RESULTS FOR 4 PATIENT SAMPLES ON A COBAS 8000 COBAS C 502 MODULE. THE PATHOLOGIST QUESTIONED THE RESULTS AS THEY DID NOT MEET THE PATIENTS' CLINICAL PICTURES. ON (B)(6) 2026, SAMPLE 1 HAD AN INITIAL RESULT OF 496 MG/DL. THE SAMPLE WAS REPEATED TWICE AND THE RESULTS WERE 1196 MG/DL AND 1267 MG/DL. THE RESULT OF 1196 MG/DL WAS DEEMED CORRECT. ON (B)(6) 2026, SAMPLE 2 HAD AN INITIAL RESULT OF 561 MG/DL. THE SAMPLE WAS REPEATED TWICE AND THE RESULTS WERE 1245 MG/DL AND 1280 MG/DL. THE RESULT OF 1245 MG/DL WAS DEEMED CORRECT. ON (B)(6) 2026, SAMPLE 3 HAD AN INITIAL RESULT OF 1159 MG/DL. THE SAMPLE WAS REPEATED TWICE AND THE RESULTS WERE 2256 MG/DL AND 2039 MG/DL. THE RESULT OF 2256 MG/DL WAS DEEMED CORRECT. ON (B)(6) 2026, SAMPLE 4 HAD AN INITIAL RESULT OF 199 MG/DL. THE INITIAL RESULT WAS NOT REPORTED OUTSIDE OF THE LABORATORY. THE SAMPLE WAS REPEATED TWICE AND THE RESULTS WERE 499 MG/DL AND 505 MG/DL. THE RESULT OF 499 MG/DL WAS DEEMED CORRECT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 24897323 ↗
• MalfunctionApr 8, 2026Labelling, Instructions for Use or Training Problem

  THE INITIAL REPORTER RECEIVED QUESTIONABLE PHNY2 PHENYTOIN ASSAY RESULTS FROM SEVERAL PATIENT SAMPLES COLLECTED IN SAMPLE TUBES WITH A GEL-SEPARATOR TESTED ON THE COBAS 8000 COBAS C 502 MODULE. THE REPORTER PROVIDED ONE PATIENT SAMPLE WITH DISCREPANT RESULTS: THE INITIAL RESULT FROM THE MODULE WAS 22 UG/ML THE REPEAT RESULT FROM ANOTHER COBAS ANALYZER WAS 31.3 UG/ML. THE PATIENT'S FAMILY QUESTIONED THE INITIAL RESULT AFTER RECEIVING THE RESULT OF A SECOND TEST. NO RESULT WAS DEEMED CORRECT, AS THE CUSTOMER BELIEVES THAT THE SEPARATOR GEL IN THE PATIENT SAMPLE TUBE MAY HAVE CAUSED THE QUESTIONABLE RESULTS.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 24815197 ↗
• MalfunctionApr 3, 2026High Test Results

  THERE WAS AN ALLEGATION OF QUESTIONABLE MICROALBUMIN RESULTS FOR 2 PATIENT SAMPLE ON A COBAS 8000 COBAS C 502 MODULE. SAMPLE 1: THE INITIAL RESULT WAS 3.3 MG/DL, AND THE REPEATED RESULT WAS 0.5 MG/DL. SAMPLE 2: THE INITIAL RESULT WAS 4.3 MG/DL, AND THE REPEATED RESULT WAS 2.5 MG/DL. THE REPEATED RESULTS WERE BELIEVED TO BE CORRECT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 24782095 ↗
• MalfunctionApr 3, 2026False Positive Result; Incorrect, Inadequate or Imprecise Result or Readings

  THERE WAS AN ALLEGATION OF A FALSE POSITIVE ONLINE DAT BENZODIAZEPINES II RESULT FOR 1 PATIENT SAMPLE ON A COBAS 8000 COBAS C 502 MODULE. THE INITIAL RESULT WAS 502 NG/ML. THE SAMPLE WAS REPEATED BECAUSE THE CUSTOMER QUESTIONED THE INITIAL RESULT. THE REPEATED RESULT WAS 42 NG/ML. THE CUSTOMER USES A CUTOFF OF 200 NG/ML. THE REPEATED RESULT WAS CONFIRMED TO BE CORRECT BASED ON THE (MASS SPECTROMETRY) CONFIRMATORY TESTING RESULTS (EXACT METHOD WAS NOT PROVIDED).

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 24777387 ↗
• MalfunctionApr 2, 2026Non Reproducible Results

  THE INITIAL REPORTER STATED THEY RECEIVED DISCREPANT RESULTS FOR ONE PATIENT SAMPLE TESTED WITH THE LITHIUM ASSAY ON A COBAS 8000 C 502 MODULE. THE PATIENT HAD AN INDICATION OF VOLUNTARY LITHIUM ADMINISTRATION. TESTING PERFORMED ON THE PATIENT ON (B)(6) 2026 AND APPROXIMATELY 10 A.M. ON (B)(6) 2026 YIELDED HIGH LITHIUM VALUES. AT 3:00 P.M. ON (B)(6) 2026, A SAMPLE WAS COLLECTED FROM THE PATIENT AND TESTED, RESULTING IN A LITHIUM VALUE OF 0.39 MMOL/L. ANOTHER SAMPLE COLLECTED FROM THE PATIENT AT 8:00 P.M. ON (B)(6) 2026 RESULTED IN A LITHIUM VALUE OF 1.96 MMOL/L. WHEN THIS VALUE WAS COMPARED TO PREVIOUS RESULTS, THE 0.39 MMOL/L RESULT FROM THE 3:00 P.M. SAMPLE WAS THEN QUESTIONED. THE 3:00 P.M. SAMPLE FROM ON (B)(6) 2026 WAS THEN REPEATED, RESULTING IN A LITHIUM VALUE OF 1.54 MMOL/L WITH A DATA FLAG. THE 3:00 P.M. SAMPLE FROM ON (B)(6) 2026 WAS REPEATED AGAIN ON (B)(6) 2026, RESULTING IN A LITHIUM VALUE OF "1.70 - 1.64" MMOL/L WITH A DATA FLAG. NO SPECIFIC VALUE WAS PROVIDED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 24764510 ↗
• MalfunctionMar 30, 2026Incorrect, Inadequate or Imprecise Result or Readings; Low Test Results

  THERE WAS AN ALLEGATION OF A QUESTIONABLE ONLINE TDM VALPROIC ACID RESULT FROM THE COBAS 8000 COBAS C 502 MODULE FOR ONE PATIENT. THE INITIAL RESULT WAS 0.04 G/ML, AND THE REPEAT RESULT WAS 93.33 G/ML. THE REPEAT RESULT WAS DEEMED TO BE CORRECT. THE SAMPLE WAS REPEATED AFTER THE PHYSICIAN QUESTIONED THE INITIAL RESULT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 24716549 ↗
• MalfunctionMar 26, 2026Non Reproducible Results

  THERE WAS AN ALLEGATION OF QUESTIONABLE TINA-QUANT ALBUMIN GEN.2 RESULTS FOR 1 PATIENT SAMPLE ON A COBAS 8000 COBAS C 502 MODULE. THE INITIAL RESULT WAS 51.73 MG/DL, AND THE REPEATED RESULT WAS 34.89 MG/DL. THE REPEATED RESULT WAS OBTAINED ON ANOTHER MODULE AND WAS BELIEVED TO BE CORRECT. THE SAMPLE WAS REPEATED BECAUSE THE CUSTOMER EXPERIENCED ISSUES WITH QC.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 24696983 ↗
• MalfunctionMar 20, 2026High Test Results

  THE INITIAL REPORTER RECEIVED QUESTIONABLE TINA-QUANT HEMOGLOBIN A1C GEN.3 - HEMOLYSATE AND WHOLE BLOOD APPLICATION ASSAY RESULTS FROM ONE PATIENT'S SAMPLE TESTED ON THE COBAS 8000 COBAS C 502 MODULE. THE INITIAL RESULT FROM THE ANALYZER WAS AN INVALIDATING DATA FLAG. THE FIRST REPEAT RESULT FROM THE ANALYZER WAS AN INVALIDATING DATA FLAG. THE CUSTOMER PLACED THE PATIENT SAMPLE TUBE ON A QC RACK, AS THEY HAVE A "NORMAL PRACTICE" OF RUNNING THE PATIENT SAMPLES AS QCS WHEN ERRONEOUS RESULTS ARE PRODUCED. THE SECOND REPEAT RESULT WITH THE PATIENT SAMPLE TUBE IN A QC RACK IS 14.53%. THE THIRD AND FOURTH REPEAT RESULTS WITH THE PATIENT SAMPLE TUBE IN A QC RACK IS 9.20% AND 9.30%. THE FIFTH REPEAT RESULT FROM ANOTHER LABORATORY DEPARTMENT'S SEBIA CAPILLARYS 3 OCTA ANALYZER WAS APPROXIMATELY 5%. THIS RESULT WAS DEEMED CORRECT. NO QUESTIONABLE RESULT WAS REPORTED OUTSIDE OF THE LABORATORY.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 24651004 ↗
• MalfunctionMar 18, 2026Low Test Results

  THE INITIAL REPORTER QUESTIONED LOW RESULTS FOR MULTIPLE PATIENT SAMPLES TESTED FOR UREA/BUN ON A COBAS 8000 COBAS C 502 MODULE. DISCREPANT RESULTS WERE PROVIDED FOR 1 PATIENT SAMPLE. THE INITIAL RESULT WAS 9.7 MMOL/L. THE REPEAT RESULT WAS 14.4 MMOL/L. THE SAMPLE WAS REPEATED ON A DIFFERENT C502 MODULE WITH A RESULT OF 14.6 MMOL/L.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 24626248 ↗
• MalfunctionMar 11, 2026High Test Results

  THERE WAS AN ALLEGATION OF QUESTIONABLE RESULTS FROM THE COBAS 8000 COBAS C 502 MODULE. OF THE DATA PROVIDED, ONE EXAMPLE WAS A REPORTABLE MALFUNCTION. THE INITIAL RESULT WAS 6.84% AND THE REPEAT RESULT ON (B)(6) 2026 USING A COBAS C501 ANALYZER WAS 6.29% WITH A DATA FLAG.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 24575807 ↗
• MalfunctionMar 11, 2026High Test Results

  WE RECEIVED AN ALLEGATION ABOUT DISCREPANT RESULTS FOR 2 PATIENTS' SAMPLES TESTED WITH ONLINE TDM VANCOMYCIN GEN. 3 ASSAY ON A COBAS 8000 COBAS C 502 MODULE. PATIENT 1: INITIAL RESULT: 70.7 UG/ML (ACCOMPANIED BY ">CRITICAL RANGE" DATA FLAG). REPEAT RESULT: 15.9 UG/ML. PATIENT 2: INITIAL RESULT: 42.9 UG/ML (ACCOMPANIED BY ">CRITICAL RANGE" DATA FLAG). REPEAT RESULT: 8.9 UG/ML. THE CLINICIAN/PHARMACY QUESTIONED THE INITIAL RESULTS, PROMPTING THE ORIGINAL SAMPLES FOR PATIENT 1 AND PATIENT 2 TO BE REPEATED ON A DIFFERENT ANALYZER AND THE TEST TO BE REORDERED. THE REPEAT VALUES WERE DEEMED CORRECT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 24575712 ↗

Recalls under the same FDA submission

These recalls involve devices cleared under K100853. One submission often covers many models, so check the product and lot details in each record.

• Z-0754-2021 · Dec 8, 2020 · Open, Classified
  Roche cobas 8000 modular analyzer series (i.e., cobas 8000 ISE module; cobas c 502, 701, and 702 modules; and cobas e 602 and 801 modules). Chemistry Analyzer (photometric discrete
• Z-2477-2019 · Jul 18, 2019 · Terminated
  Cobas 8000 Modular Analyzer Series: cobas 8000 ISE module part Numbers : 05964075001 cobas c 701 module part Numbers : 05641489001 cobas c 702 module part Numbers : 06473245
• 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
• Z-0675-2018 · Jul 28, 2017 · Terminated
  Cobas 8000 Modular Series system; Software Version 05-02 and 06-03; UDI: 05641446001
• Z-0910-2018 · Jul 18, 2017 · Terminated
  cobas 8000 Modular Analyzer Series; Part Numbers: 1. 05964067001 cobas 8000 c 502 module
• Z-0378-2018 · Jun 29, 2017 · Terminated
  Brand Name: cobas c 6000 MODULAR Series System e 601 cobas c 8000 MODULAR Series System - e 602 Roche / Hitachi MODULAR Analytics Combination System Model/Catalog/Part Number
• Z-2049-2017 · Mar 21, 2017 · Terminated
  Sample probes associated with: cobas 6000 Series System, cobas 8000 Modular Analyzer Series, cobas c 311 analyzer cobas c 501/502 cobas c 701/702 cobas 8000 ISE Product Usage: Th
• Z-0097-2017 · Jul 15, 2016 · Terminated
  cobas 8000 Modular Analyzer Series c8000, Chemistry (Photometric, Discrete) for clinical use Modular e602: Immunoassay Analyzer Product Usage: The VS II system is a stand-alone, c
• Z-1449-2014 · Mar 13, 2014 · Terminated
  Cobas c8000 Modular Analyzer Series Cobas c502, Part Number 5964067001, a clinical chemistry analyzer intended for the in vitro quantitative / qualitative determination of analyt
• Z-1368-2013 · Apr 4, 2013 · Terminated
  Cobas 8000 modular analyzer series software version 03-01, 02, 03 and 04, impacting the cobas e 602 module only. Product Usage: Fully automated immunoassay analyzer intended for