Albumin Gen.2 08056714190Recalls & reported problems

Summary

The FDA's MAUDE database contains 5 adverse event reports that list this exact device (DI 07613336120958), received between Jul 23, 2025 and Sep 17, 2026 — classified as 5 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 5 most recent of 5 reports, in the reporter's own words as published by the FDA.

• MalfunctionSep 17, 2026Incorrect, Inadequate or Imprecise Result or Readings

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 50805531 ↗
• MalfunctionJan 28, 2026Low Test Results

  THERE WAS AN ALLEGATION OF QUESTIONABLE ALBUMIN BCP RESULTS FOR 25 PATIENT SAMPLES ON A COBAS PURE C 303 ANALYTICAL UNIT. THE CUSTOMER QUESTIONED THE RESULTS AS THE ALBUMIN RESULTS WERE LOW BUT THE TOTAL PROTEIN RESULTS WERE NORMAL IN PATIENTS THAT DO NOT HAVE KIDNEY DISEASE. REFER TO THE ATTACHMENT TO THE MEDWATCH FOR ALL PATIENT DATA. THE UNITS OF MEASUREMENT FOR TOTAL PROTEIN WERE NOT PROVIDED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 24199417 ↗
• MalfunctionNov 19, 2025Incorrect, Inadequate or Imprecise Result or Readings; Incorrect, Inadequate or Imprecise Result or Readings

  THERE WAS AN ALLEGATION OF QUESTIONABLE ALBUMIN BCP RESULTS FROM THE COBAS PURE C 303 ANALYTICAL UNIT THAT DID NOT MATCH THE CLINICAL PICTURE. FOR MULTIPLE PATIENT SAMPLES, THE ALBUMIN RESULTS WERE LOW, BUT THE TOTAL PROTEIN RESULTS WERE NORMAL WITHOUT ANY SPECIFIC DIAGNOSIS RELATED TO LOW ALBUMIN RESULTS. TWO REPRESENTATIVE EXAMPLES: EXAMPLE 1: ON (B)(6) 2025, THE ALBUMIN RESULT WAS 33.80 G/L AND THE TOTAL PROTEIN RESULT WAS 69.9 G/L. EXAMPLE 2: ON (B)(6) 2025, THE ALBUMIN RESULT WAS 37.3 G/L AND THE TOTAL PROTEIN RESULT WAS 75.1 G/L. THE SAMPLES WERE REPEATED ON ANOTHER COBAS C303 AND A COBAS C503 ANALYZERS, AND THE RESULTS WERE IDENTICAL. THE SAMPLES WERE REPEATED USING THE "ALB-G" ASSAY, AND THE RESULTS WERE SLIGHTLY HIGHER BUT STILL LOW. NO SPECIFIC DATA WAS PROVIDED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 23593030 ↗
• MalfunctionAug 18, 2025Low Test Results; Low Test Results

  THERE WAS AN ALLEGATION OF QUESTIONABLE ALBUMIN BCP RESULTS FROM THE COBAS PURE C 303 ANALYTICAL UNIT. THE INITIAL RESULT WAS 27G/L. THE SAMPLE WAS THEN SENT TO ANOTHER LAB AS PART OF THE NETWORKS IQAP AND WAS RETESTED ON A COBAS C 701 WITH A RESULT OF 37.3 G/L. THIS RESULT WAS BELIEVED TO BE CORRECT, AND THE REPORTED RESULT WAS AMENDED. AN EDTA SAMPLE FROM THE SAME VENIPUNCTURE OF THE PATIENT WAS TESTE,D AND THE RESULT WAS 40 G/L.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 22826934 ↗
• MalfunctionJul 23, 2025Low Test Results; Non Reproducible Results; Low Test Results; Non Reproducible Results

  THE INITIAL REPORTER RECEIVED QUESTIONABLE ALBUMIN BCP RESULTS FROM SOME PATIENT SAMPLES TESTED ON THE COBAS C 503 ANALYTICAL UNIT. THE RESULTS FROM THE ANALYZER WERE COMPARED TO TWO COMPETITOR ANALYZERS (COMPETITOR 1 AND COMPETITOR 2). COMPETITOR 1'S LABORATORY METHOD IS UNKNOWN; COMPETITOR 2 USES THE BROMOCRESOL GREEN (BCG) LABORATORY METHOD. THE REPORTER PROVIDED THE FOLLOWING EXAMPLES OF QUESTIONABLE RESULTS: PATIENT SAMPLE 1 THE INITIAL RESULT FROM THE ANALYZER IS 29 G/L. THE REPEAT RESULT FROM COMPETITOR 1 IS 36 G/L. THE REPEAT RESULT FROM COMPETITOR 2 IS 36 G/L. PATIENT SAMPLE 2 THE INITIAL RESULT FROM THE ANALYZER IS 28 G/L. THE REPEAT RESULT FROM COMPETITOR 1 IS 34 G/L. THE REPEAT RESULT FROM COMPETITOR 2 IS 34 G/L. PATIENT SAMPLE 3 THE INITIAL RESULT FROM THE ANALYZER IS 41 G/L. THE REPEAT RESULT FROM COMPETITOR 1 IS 47 G/L. THE REPEAT RESULT FROM COMPETITOR 2 IS 48 G/L. THE REPORTER STATED THAT THE DIFFERENT RESULTS FROM THE DIFFERENT ANALYZERS MAKE PATIENT CARE AND TREATMENT DIFFICULT FOR DOCTORS.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 22574524 ↗

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