Albumin Gen2 3183688122Recalls & reported problems

Summary

The FDA's MAUDE database contains 5 adverse event reports that list this exact device (DI 04015630918898), received between Jul 20, 2021 and Jul 31, 2025 — classified as 5 malfunctions.

The most frequently reported specific device problem is “Low Test Results” (4 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 5 most recent of 5 reports, in the reporter's own words as published by the FDA.

• MalfunctionJul 31, 2025Incorrect Measurement; Incorrect Measurement

  THERE WAS AN ALLEGATION OF 10 QUESTIONABLE ALBUMIN GEN.2 RESULTS FROM THE COBAS 6000 C (501) MODULE. ONLY THE DATA FOR 2 OF THE PATIENTS WERE PROVIDED, AND ARE A REPORTABLE MALFUNCTION. PATIENT 1'S INITIAL RESULT WAS 0.42 G/DL, AND THE REPEAT RESULT FROM ANOTHER INSTRUMENT WAS 4.22 G/DL PATIENT 2'S INITIAL RESULT WAS 0.47 G/DL, AND THE REPEAT RESULT FROM ANOTHER INSTRUMENT WAS 4.78 G/DL. THE REPEAT RESULTS WERE DEEMED TO BE CORRECT. THE INITIAL RESULTS WERE REPEATED BECAUSE THE DOCTOR OR TECHNICIAN QUESTIONED THE CRITICAL RESULTS.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 22676057 ↗
• MalfunctionSep 11, 2023Incorrect, Inadequate or Imprecise Result or Readings; Low Test Results; Incorrect, Inadequate or Imprecise Result or Readings; Low Test Results

  WE RECEIVED AN ALLEGATION ABOUT DISCREPANT RESULTS FOR 20 PATIENTS' SAMPLES TESTED WITH ALBUMIN (ALB2) ASSAY ON A COBAS 8000 COBAS C502 ANALYZER. THE CUSTOMER STATED THAT THE RESULTS FOR THE 20 PATIENTS' SAMPLE WERE LESS THAN 3 G/DL WHILE THEIR PREVIOUS RESULTS WERE CLOSE TO 5 G/DL. DISCREPANT RESULTS FOR 2 PATIENTS' SAMPLES WERE PROVIDED. SAMPLE 1: INITIAL RESULT: 2.44 G/DL. REPEAT RESULT: 4.3 G/DL. SAMPLE 2: INITIAL RESULT: 2.66 G/DL. REPEAT RESULT: 4.56 G/DL. THE REPEAT RESULTS WERE DEEMED TO BE CORRECT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 17719453 ↗
• MalfunctionJan 4, 2023Incorrect, Inadequate or Imprecise Result or Readings; Low Test Results; Incorrect, Inadequate or Imprecise Result or Readings; Low Test Results

  THE INITIAL REPORTER STATED THEY RAN PATIENT SAMPLES AS PART OF A LOT-TO-LOT COMPARISON ON THE COBAS 8000 C 502 MODULE WHEN STARTING A NEW LOT OF ALB2 ALBUMIN GEN.2. TWO PATIENT SAMPLES HAD DISCREPANT RESULTS FOR ALBUMIN. WHEN TESTED WITH THE OLD LOT (LOT 64818101), THE FIRST SAMPLE INITIALLY RESULTED IN AN ALBUMIN VALUE OF 2.60 G/DL AND THIS VALUE WAS REPORTED OUTSIDE OF THE LABORATORY. THE SAMPLE WAS REPEATED TWICE WITH THE NEW LOT (LOT 657589), RESULTING IN VALUES OF 4.37 G/DL AND 4.36 G/DL. THE REPEAT VALUES WERE DEEMED CORRECT. WHEN TESTED WITH THE OLD LOT (LOT 64818101), THE SECOND SAMPLE INITIALLY RESULTED IN AN ALBUMIN VALUE OF 2.54 G/DL AND THIS VALUE WAS REPORTED OUTSIDE OF THE LABORATORY. THE SAMPLE WAS REPEATED TWICE WITH THE NEW LOT (LOT 657589), RESULTING IN VALUES OF 4.80 G/DL AND 4.79 G/DL. THE REPEAT VALUES WERE DEEMED CORRECT. THE SERIAL NUMBER OF THE C 502 ANALYZER IS (B)(4).

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 16096673 ↗
• MalfunctionOct 31, 2022Low Test Results; Low Test Results

  THE INITIAL REPORTER STATED THEY RECEIVED DISCREPANT RESULTS FOR ONE PATIENT SAMPLE TESTED WITH ALB2 ALBUMIN GEN.2 ON A COBAS 8000 C 502 MODULE. THE SAMPLE INITIALLY RESULTED IN AN ALBUMIN VALUE OF 1.31 G/DL AND THIS VALUE WAS REPORTED OUTSIDE OF THE LABORATORY. AS THE VALUE WAS CONSIDERED CRITICAL, THE SAMPLE WAS REPEATED, RESULTING IN A VALUE OF 1.84 G/DL. THE REPEAT VALUE WAS DEEMED CORRECT. THE ALBUMIN REAGENT LOT NUMBER AND EXPIRATION DATE WERE REQUESTED, BUT NOT PROVIDED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 15698042 ↗
• MalfunctionJul 20, 2021Low Test Results; Non Reproducible Results; Low Test Results; Non Reproducible Results

  THE INITIAL REPORTER RECEIVED QUESTIONABLE ALB2 ALBUMIN GEN.2 RESULTS FOR ONE PATIENT THE COBAS 6000 C501 MODULE SERIAL NUMBER (B)(4) COMPARED TO A COMPETITOR¿S PLATFORM. THE REPORTER STATED THE SAME SAMPLE WAS TESTED ON 3 COBAS SYSTEMS (TWICE ON A 6000 AND ONCE ON AN 8000) AND ALL THREE WERE NON-COMPARABLE WITH THE COMPETITOR PLATFORM. THE REPORTER PROVIDED THE FOLLOWING EXAMPLES: THE C501 RESULT WAS 0.8 G/DL. THE COMPETITOR RESULT WAS 3.2 G/DL. THE C501 RESULT WAS 0.02 G/DL. THE COMPETITOR RESULT WAS 2.42 G/DL. THE QUESTIONABLE RESULTS WERE NOT REPORTED OUTSIDE OF THE LABORATORY.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 12196697 ↗

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