Albumin Gen2 5166861190Recalls & reported problems

Summary

The FDA's MAUDE database contains 8 adverse event reports that list this exact device (DI 04015630924820), received between Jul 12, 2018 and Dec 5, 2024 — classified as 8 malfunctions.

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

3 other recalls cover devices cleared under the same FDA submission (K033009); 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.

• MalfunctionDec 5, 2024Incorrect, Inadequate or Imprecise Result or Readings; Incorrect, Inadequate or Imprecise Result or Readings

  THERE WAS AN ALLEGATION OF QUESTIONABLE ALBUMIN GEN.2 ASSAY RESULTS FOR TWO PATIENT SAMPLES ON A COBAS 8000 C702 MODULE. BOTH SAMPLES WERE REPEATED AS THE RESULTS DID NOT MATCH THE PATIENT'S HISTORY. SAMPLE 1: THE INITIAL RESULT WAS < 2 G/L. THE REPEATED RESULT WAS 51.5 G/L. SAMPLE 2: THE INITIAL RESULT WAS < 2 G/L. THE REPEATED RESULT WAS 44 G/L. NONE OF THE RESULTS WERE REPORTED OUT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 20856508 ↗
• MalfunctionMay 22, 2023Low Test Results; Non Reproducible Results; Low Test Results; Non Reproducible Results

  WE RECEIVED AN ALLEGATION ABOUT DISCREPANT RESULTS FOR 3 PATIENTS' SAMPLES TESTED WITH ALBUMIN (ALB2) ASSAY ON A COBAS 8000 COBAS C701 MODULE. DISCREPANT RESULT FOR ONE SAMPLE WAS PROVIDED AND THE PATIENT'S SAMPLE WAS A PLASMA SAMPLE. INITIAL RESULT: 2.93 G/DL. REPEAT RESULT: 3.45 G/DL. THE QUESTIONABLE RESULT WAS REPORTED OUTSIDE THE LABORATORY. QC HAD DROPPED OUT BY 3SD PROMPTING THE RERUN OF THE SAMPLE. THE RERUN RESULT WAS DEEMED TO BE CORRECT. A REPORT WITH THE CORRECTED RESULTS FOR THE 3 SAMPLES WAS REPORTED OUTSIDE THE LABORATORY. THE ALB2 REAGENT LOT NUMBER WAS 67564801 WITH AN EXPIRATION DATE OF 29-FEB-2024.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 16975586 ↗
• MalfunctionDec 21, 2021Incorrect, Inadequate or Imprecise Result or Readings; Low Test Results; Incorrect, Inadequate or Imprecise Result or Readings; Low Test Results

  THE INITIAL REPORTER RECEIVED QUESTIONABLE ALB2 ALBUMIN GEN.2 AND TP2 TOTAL PROTEIN GEN.2 RESULTS FOR ONE PATIENT FROM DIFFERENT SAMPLES WITH COBAS 8000 C702 MODULE SERIAL NUMBERS (B)(4). THE REPORTER STATED THE PATIENT¿S ALBUMIN LEVEL HAS BEEN SLOWLY DECLINING OVER THE PAST FEW DAYS WITH TOTAL PROTEIN LEVELS INCREASING SLIGHTLY. THE CUSTOMER SUSPECTS AN INTERFERENCE AS THE RESULTS DO NOT MATCH THE CLINICAL PICTURE OF THE PATIENT. SAMPLE (B)(6): TESTED ON SERIAL NUMBER (B)(4). THE INITIAL ALB RESULT AT 11:31 WAS 4.5 G/L. THE REPEATED RESULT AT 12:12 WAS 4 G/L. THE SECOND REPEATED RESULT AT 13:57 WAS 3.9 G/L. THE THIRD REPEATED RESULT AT 14:46 WAS 4.6 G/L. THE TP RESULT WAS 71.5 G/L. SAMPLE(B)(6): TESTED ON SERIAL NUMBER (B)(4) (INITIAL RESULT) AND (B)(4) (REPEATED RESULT) THE INITIAL ALB RESULT AT 19:54 WAS 3.4 G/L. THE REPEATED RESULT AT 22:00 WAS 4.1 G/L. THE TP RESULT WAS 73.3 G/L. SAMPLE (B)(6): TESTED ON SERIAL NUMBER (B)(4). ON (B)(6) 2021, THE ALB RESULT WAS 3.7 G/L. THE TP RESULT WAS 70.8 G/L. THE QUESTIONABLE ALBUMIN RESULTS WERE NOT REPORTED OUTSIDE OF THE LABORATORY. IT IS UNKNOWN IF THE QUESTIONABLE TOTAL PROTEIN RESULTS WERE REPORTED OUTSIDE OF THE LABORATORY. THIS MED

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 13054105 ↗
• MalfunctionAug 9, 2018High Test Results; High Test Results

  THE CUSTOMER STATED THAT THEY RECEIVED QUESTIONABLE RESULTS FOR TWO PATIENT SAMPLES TESTED FOR ALB2 ALBUMIN GEN.2 ON A COBAS 8000 CORE UNIT. OF THE TWO SAMPLES, ONE HAD AN ERRONEOUS ALB2 RESULT. THE ERRONEOUS RESULT WAS NOT REPORTED OUTSIDE OF THE LABORATORY. THE SAMPLE INITIALLY RESULTED WITH AN ALB2 VALUE OF 99.2 G/L, WHICH REPEATED AS 53.3 G/L. NO ADVERSE EVENTS WERE ALLEGED TO HAVE OCCURRED WITH THE PATIENT. THE ALB2 REAGENT LOT NUMBER WAS 291850, WITH AN EXPIRATION DATE OF 30-JAN-2019. THE ANALYZER WASHING STATION WAS NOT FLUSHING AND THIS WAS RESOLVED.

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 7767396 ↗
• MalfunctionJul 12, 2018Non Reproducible Results; Non Reproducible Results

  THE CUSTOMER COMPLAINED OF DISCREPANT RESULTS FOR MULTIPLE TESTS FOR 1 PATIENT SAMPLE ON A COBAS 8000 C 702 MODULE, AN ISE MODULE, AND A COBAS 8000 E 801 MODULE THAT WAS PROCESSED ON A COBAS P 612 PRE-ANALYTICAL SYSTEM. REFER TO THE MEDWATCH PATIENT IDENTIFIERS (B)(6) FOR ALL OF THE MODULES INVOLVED. REFER TO THE ATTACHMENT TO THE MEDWATCH FOR ALL PATIENT DATA. ERRONEOUS RESULTS WERE REPORTED OUTSIDE OF THE LABORATORY. THERE WAS NO ALLEGATION OF AN ADVERSE EVENT. THE CUSTOMER WAS UNCERTAIN IF A SAMPLE MISMATCH OCCURRED FOR THE INITIAL RESULTS. THE REAGENT LOT NUMBERS AND EXPIRATION DATES WERE ASKED FOR BUT NOT PROVIDED. THE QC, SAMPLE PROBE ADJUSTMENTS, AND A PRECISION CHECK WERE ACCEPTABLE. A PRECISION CHECK WAS PERFORMED. THE CUSTOMER REPEATED 11 SAMPLES ON THE C 702 AND E 801 MODULES AND FOUND TO BE COMPARABLE. THE INVESTIGATION WAS UNABLE TO FIND A DEFINITIVE ROOT CAUSE.

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 7681932 ↗
• MalfunctionJul 12, 2018Non Reproducible Results; Non Reproducible Results

  THE CUSTOMER COMPLAINED OF DISCREPANT RESULTS FOR MULTIPLE TESTS FOR 1 PATIENT SAMPLE ON A COBAS 8000 C 702 MODULE, AN ISE MODULE, AND A COBAS 8000 E 801 MODULE THAT WAS PROCESSED ON A COBAS P 612 PRE-ANALYTICAL SYSTEM. REFER TO THE MEDWATCH PATIENT IDENTIFIERS (B)(6) FOR ALL OF THE MODULES INVOLVED. REFER TO THE ATTACHMENT TO THE MEDWATCH FOR ALL PATIENT DATA. ERRONEOUS RESULTS WERE REPORTED OUTSIDE OF THE LABORATORY. THERE WAS NO ALLEGATION OF AN ADVERSE EVENT. THE CUSTOMER WAS UNCERTAIN IF A SAMPLE MISMATCH OCCURRED FOR THE INITIAL RESULTS. THE REAGENT LOT NUMBERS AND EXPIRATION DATES WERE ASKED FOR BUT NOT PROVIDED. THE QC, SAMPLE PROBE ADJUSTMENTS, AND A PRECISION CHECK WERE ACCEPTABLE. A PRECISION CHECK WAS PERFORMED. THE CUSTOMER REPEATED 11 SAMPLES ON THE C 702 AND E 801 MODULES AND FOUND TO BE COMPARABLE. THE INVESTIGATION WAS UNABLE TO FIND A DEFINITIVE ROOT CAUSE.

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 7681927 ↗
• MalfunctionJul 12, 2018Non Reproducible Results; Non Reproducible Results

  THE CUSTOMER COMPLAINED OF DISCREPANT RESULTS FOR MULTIPLE TESTS FOR 1 PATIENT SAMPLE ON A COBAS 8000 C 702 MODULE, AN ISE MODULE, AND A COBAS 8000 E 801 MODULE THAT WAS PROCESSED ON A COBAS P 612 PRE-ANALYTICAL SYSTEM. REFER TO THE MEDWATCH PATIENT IDENTIFIERS (B)(6) FOR ALL OF THE MODULES INVOLVED. REFER TO THE ATTACHMENT TO THE MEDWATCH FOR ALL PATIENT DATA. ERRONEOUS RESULTS WERE REPORTED OUTSIDE OF THE LABORATORY. THERE WAS NO ALLEGATION OF AN ADVERSE EVENT. THE CUSTOMER WAS UNCERTAIN IF A SAMPLE MISMATCH OCCURRED FOR THE INITIAL RESULTS. THE REAGENT LOT NUMBERS AND EXPIRATION DATES WERE ASKED FOR BUT NOT PROVIDED. THE QC, SAMPLE PROBE ADJUSTMENTS, AND A PRECISION CHECK WERE ACCEPTABLE. A PRECISION CHECK WAS PERFORMED. THE CUSTOMER REPEATED 11 SAMPLES ON THE C 702 AND E 801 MODULES AND FOUND TO BE COMPARABLE. THE INVESTIGATION WAS UNABLE TO FIND A DEFINITIVE ROOT CAUSE.

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 7681922 ↗
• MalfunctionJul 12, 2018Non Reproducible Results; Non Reproducible Results

  THE CUSTOMER COMPLAINED OF DISCREPANT RESULTS FOR MULTIPLE TESTS FOR 1 PATIENT SAMPLE ON A COBAS 8000 C 702 MODULE, AN ISE MODULE, AND A COBAS 8000 E 801 MODULE THAT WAS PROCESSED ON A COBAS P 612 PRE-ANALYTICAL SYSTEM. REFER TO THE MEDWATCH PATIENT IDENTIFIERS (B)(6) FOR ALL OF THE MODULES INVOLVED. REFER TO THE ATTACHMENT TO THE MEDWATCH FOR ALL PATIENT DATA. ERRONEOUS RESULTS WERE REPORTED OUTSIDE OF THE LABORATORY. THERE WAS NO ALLEGATION OF AN ADVERSE EVENT. THE CUSTOMER WAS UNCERTAIN IF A SAMPLE MISMATCH OCCURRED FOR THE INITIAL RESULTS. THE REAGENT LOT NUMBERS AND EXPIRATION DATES WERE ASKED FOR BUT NOT PROVIDED. THE QC, SAMPLE PROBE ADJUSTMENTS, AND A PRECISION CHECK WERE ACCEPTABLE. A PRECISION CHECK WAS PERFORMED. THE CUSTOMER REPEATED 11 SAMPLES ON THE C 702 AND E 801 MODULES AND FOUND TO BE COMPARABLE. THE INVESTIGATION WAS UNABLE TO FIND A DEFINITIVE ROOT CAUSE.

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 7681913 ↗

Recalls under the same FDA submission

These recalls involve devices cleared under K033009. One submission often covers many models, so check the product and lot details in each record.

• Z-0104-2021 · Aug 27, 2020 · Terminated
  Albumin Gen.2, Catalog 05166861190
• Z-0152-2020 · Sep 11, 2019 · Terminated
  Roche Diagnostics cobas Integra Albumin Gen.2 Catalog Number: 05166861190 - Product Usage: In vitro test for the quantitative determination of the albumin in human serum and plasm
• Z-0011-2009 · Jun 11, 2008 · Terminated
  Roche Diagnostics ALBT2, Tina-quant Albumin Gen. 2, COBAS INTEGRA, cobas c systems, Roche Diagnostics, Indianapolis, IN.; 04469658190. An in-vitro diagnostic reagent system intend