Tina-quant Apolipoprotein A-1 ver.2 08105448190Recalls & reported problems

Summary

The FDA's MAUDE database contains 2 adverse event reports that list this exact device (DI 07613336133521), received between Oct 25, 2023 and Aug 13, 2024 — classified as 2 malfunctions.

The most frequently reported specific device problem is “High Test Results” (1 report).

1 other recall cover devices cleared under the same FDA submission (K013249); 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 2 most recent of 2 reports, in the reporter's own words as published by the FDA.

• MalfunctionAug 13, 2024Low Test Results; Low Test Results

  THE INITIAL REPORTER COMPLAINED OF A DISCREPANT LOW RESULT FOR 1 PATIENT SAMPLE TESTED FOR TINA-QUANT APOLIPOPROTEIN A-1 VER.2 (APOAT) ON A COBAS C 503 ANALYTICAL UNIT. THE INITIAL RESULT WAS 0.489 G/L. THE SAMPLE WAS REPEATED BY A COMPETITOR METHOD AND THE RESULT WAS "DISCREPANT." THE SPECIFIC RESULT WAS NOT PROVIDED. THE SAMPLE WAS REPEATED ON THE C503 ANALYZER USING A 1:2 DILUTION AND THE RESULT WAS 0.85 G/L. A NEW SAMPLE WAS OBTAINED AND THE INITIAL RESULT ON THE C503 ANALYZER WAS 0.8 G/L. THE SAMPLE WAS REPEATED USING A 1:2 DILUTION AND THE RESULT WAS 0.924 G/L.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 19972879 ↗
• MalfunctionOct 25, 2023Incorrect Measurement; Incorrect, Inadequate or Imprecise Result or Readings; High Test Results; No Apparent Adverse Event; Non Reproducible Results; Incorrect Measurement; Incorrect, Inadequate or Imprecise Result or Readings; High Test Results; No Apparent Adverse Event; Non Reproducible Results

  THE INITIAL REPORTER STATED THEY RECEIVED DISCREPANT RESULTS FOR ONE PATIENT SAMPLE TESTED WITH APOAT (APOLIPOPROTEIN A) ON A COBAS PRO C 503 ANALYTICAL UNIT. NO QUESTIONABLE RESULTS WERE REPORTED OUTSIDE OF THE LABORATORY. THE SAMPLE INITIALLY RESULTED IN AN APOLIPOPROTEIN A VALUE OF 94 MG/DL. THE VALUE WAS CONSIDERED VERY HIGH SO THE SAMPLE WAS REPEATED. THE REPEAT APOLIPOROTEIN A RESULT WAS 45 MG/DL. THE SAMPLE WAS ALSO REPEATED TWICE ON A SECOND ANALYZER ON (B)(6) 2023, RESULTING IN APOLIPOROTEIN A VALUES OF 36 MG/DL AND 36 MG/DL. THE RESULTS FROM THE SECOND ANALYZER WERE DEEMED CORRECT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 18007436 ↗

Recalls under the same FDA submission

These recalls involve devices cleared under K013249. One submission often covers many models, so check the product and lot details in each record.

• Z-1124-2019 · Dec 14, 2018 · Terminated
  COBAS INTEGRA 400 plus analyzer used in the following assays: a)Tina-quant Apolipoprotein A-1 ver.2 Catalog Number: 03032566122 b)Tina-quant Albumin Gen.2 Catalog Number 04