Tina-quant Antistreptolysin O 5219191190Recalls & reported problems
Roche Diagnostics GmbH · Class 1
Data updated Oct 18, 2026 from official FDA records · Editorial policy
- Adverse event reports
- 2
- Deaths reported
- 0
- Injuries reported
- 0
- Recalls naming it
- 0
Summary
The FDA's MAUDE database contains 2 adverse event reports that list this exact device (DI 04015630925711), received between Aug 12, 2024 and Sep 29, 2026 — classified as 2 malfunctions.
The most frequently reported specific device problem is “Incorrect Measurement” (1 report).
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.
Reports received per month
Most reported problems
Device problems
- Incorrect Measurement1
- Low Test Results1
Patient problems
- No Clinical Signs, Symptoms or Conditions2
Recent adverse event reports
The 2 most recent of 2 reports, in the reporter's own words as published by the FDA.
MalfunctionSep 29, 2026Low Test Results
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 50937689 ↗MalfunctionAug 12, 2024Incorrect Measurement; Incorrect Measurement
THE INITIAL REPORTER COMPLAINED OF DISCREPANT RESULTS FOR 1 PATIENT SAMPLE TESTED FOR TINA-QUANT ANTISTREPTOLYSIN O (ASLO TQ) ON A COBAS 8000 C 702 MODULE. THE INITIAL RESULT WITH REAGENT LOT 748374 (EXP. 31-OCT-2024) WAS >549 IU/ML WITH AN INVALIDATING DATA FLAG. THE REPEAT RESULT USING THE SAME REAGENT LOT WITH A 1:10 DILUTION WAS >6797 IU/ML WITH AN INVALIDATING DATA FLAG. THE SAMPLE WAS REPEATED WITH A 1:20 DILUTION WITH REAGENT LOT 760770 AND THE RESULT WAS 49 IU/ML. THE PATIENT WAS TESTED IN A DIFFERENT LABORATORY AND THE RESULT WAS "ALMOST 6000." THE SAMPLE WAS REPEATED WITH A 1:20 DILUTION WITH REAGENT LOT 760770 AND THE RESULT WAS >13782 IU/ML WITH AN INVALIDATING DATA FLAG. THE SAMPLE WAS REPEATED WITH A 1:50 DILUTION USING THE SAME REAGENT LOT AND THE RESULT WAS 13411 IU/ML.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 19964431 ↗
Other ANTISTREPTOLYSIN - TITER/STREPTOLYSIN O REAGENT devices
- Tina-quant Antistreptolysin O 08105472190Roche Diagnostics GmbH · ANTISTREPTOLYSIN - TITER/STREPTOLYSIN O REAGENT1 report
Sources and updates
- Device record: FDA GUDID, file dated Oct 13, 2026 · View this device in AccessGUDID ↗
- Adverse event reports: FDA MAUDE, file dated Oct 14, 2026 · each report above links to its original FDA record
- Recalls: FDA Medical Device Recalls, file dated Oct 16, 2026
- Page last rebuilt: Oct 18, 2026. Data downloaded through openFDA, which notes it is not validated for clinical or regulatory use.
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