Albumin Gen.2 08056692190Recalls & reported problems

Summary

The FDA's MAUDE database contains 6 adverse event reports that list this exact device (DI 07613336120941), received between Sep 30, 2021 and Sep 22, 2026 — classified as 6 malfunctions.

The most frequently reported specific device problem is “Low Test Results” (3 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 6 most recent of 6 reports, in the reporter's own words as published by the FDA.

• MalfunctionSep 22, 2026Non Reproducible Results

  The initial reporter complained of a discrepant low result for 1 patient sample tested for Albumin Gen.2 (ALB2) on a cobas c 303 analytical unit.The initial result was 4.15 g/dL. The repeat result was 0.458 g/dL. The repeat result was reported outside of the laboratory, where it was questioned by the physician, as it was inconsistent with the patient¿s total protein result and clinical presentation. The initial result was believed to be correct.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 50858825 ↗
• MalfunctionAug 31, 2026Non Reproducible Results

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 50531323 ↗
• MalfunctionJul 31, 2026Low Test Results

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 50099594 ↗
• MalfunctionSep 26, 2024Low Test Results; Non Reproducible Results; Low Test Results; Non Reproducible Results

  WE RECEIVED AN ALLEGATION ABOUT DISCREPANT RESULTS FOR 1 PATIENT SAMPLE TESTED WITH ALBUMIN GEN.2 (ALB2) ASSAY AND LDHI2 ASSAY ON COBAS C503 ANALYTICAL UNIT. THIS MEDWATCH WILL APPLY TO THE ALB2 ASSAY. PLEASE REFER TO THE MEDWATCH WITH A1 PATIENT IDENTIFIER (B)(6) FOR INFORMATION RELATED TO THE LDHI2 ASSAY. ALB2: INITIAL RESULT: 1.18 G/DL. REPEAT RESULT: 3.63 G/DL. LDHI2: INITIAL RESULT: 380 U/L. REPEAT RESULT: 607 U/L. THE PHYSICIAN QUESTIONED THE INITIAL RESULT OF THE ALB2 AS IT DID NOT MATCH THE PATIENT'S CLINICAL PICTURE AND THE SAMPLE WAS THEN REPEATED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 20311050 ↗
• MalfunctionMar 14, 2022Low Test Results; Low Test Results

  THE INITIAL REPORTER RECEIVED A QUESTIONABLE ALB2 ALBUMIN GEN.2 RESULT FOR ONE PATIENT SAMPLE WITH A COBAS PRO C 503 ANALYTICAL UNIT SERIAL NUMBER (B)(4). THE INITIAL RESULT WAS <0.35 G/L. THE REPEATED RESULT WAS 8.5 G/L. ON (B)(6) 2022, THE SAMPLE WAS SENT TO ANOTHER LABORATORY AND TESTED ON AN UNKNOWN ROCHE DEVICE WHERE THE ALB2 RESULT COULD NOT BE DETERMINED. ON (B)(6) 2022, THE SAMPLE WAS TESTED WITH AN ELECTROPHORESIS METHOD WITH A RESULT OF 32.3 G/L. THE QUESTIONABLE RESULT WAS REPORTED OUTSIDE OF THE LABORATORY.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 13759227 ↗
• MalfunctionSep 30, 2021Incorrect, Inadequate or Imprecise Result or Readings; Incorrect, Inadequate or Imprecise Result or Readings

  THE INITIAL REPORTER COMPLAINED OF DISCREPANT HIGH RESULTS FOR 1 PATIENT TESTED FOR ALB2 ON A COBAS PRO C 503 ANALYTICAL UNIT COMPARED TO AN UNKNOWN TYPE OF ANALYZER IN ANOTHER LABORATORY. "SEVERAL" SAMPLES WERE OBTAINED FROM THE PATIENT. THE RESULTS FROM THE C503 UNIT WERE ALWAYS BETWEEN 25 G/L AND 27 G/L. THE RESULTS FROM THE OTHER LABORATORY WERE ALWAYS BETWEEN 15 G/L AND 17 G/L. THE RESULTS FROM THE C503 UNIT WERE REPORTED OUTSIDE OF THE LABORATORY. THE C503 UNIT SERIAL NUMBER WAS (B)(4).

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 12555648 ↗

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