Tina-quant Antistreptolysin O 08105472190Recalls & reported problems
Roche Diagnostics GmbH · Class 1
Data updated Oct 18, 2026 from official FDA records · Editorial policy
- Adverse event reports
- 1
- Deaths reported
- 0
- Injuries reported
- 0
- Recalls naming it
- 0
Summary
The FDA's MAUDE database contains 1 adverse event report that list this exact device (DI 07613336133545), received between Jun 23, 2025 and Jun 23, 2025 — classified as 1 malfunction.
The most frequently reported specific device problem is “Low Test Results” (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
- Low Test Results1
Patient problems
- No Clinical Signs, Symptoms or Conditions1
Recent adverse event reports
The 1 most recent of 1 reports, in the reporter's own words as published by the FDA.
MalfunctionJun 23, 2025Low Test Results; Low Test Results
THE INITIAL REPORTER RECEIVED QUESTIONABLE TINA-QUANT ANTISTREPTOLYSIN O RESULTS FROM ONE PATIENT SAMPLE TESTED ON THE COBAS C 503 ANALYTICAL UNIT. ON (B)(6) 2025: THE INITIAL RESULT OF THE UNDILUTED PATIENT SAMPLE WAS 295 OR 296 IU/ML. THE FIRST REPEAT RESULT OF THE UNDILUTED PATIENT SAMPLE WAS 295 IU/ML. ON (B)(6) 2025: THE SECOND REPEAT RESULT OF THE UNDILUTED PATIENT SAMPLE WAS 308 IU/ML. THE THIRD REPEAT RESULT OF THE UNDILUTED PATIENT SAMPLE WAS 310 IU/ML. THE FOURTH REPEAT RESULT FROM THE FIRST MODULE, WITH THE PATIENT SAMPLE AT 1:5 DILUTION MANUALLY ORDERED, WAS 6504 IU/ML WITH AN INVALIDATING DATA FLAG. THE FIFTH REPEAT RESULT FROM THE FIRST MODULE, WITH THE PATIENT SAMPLE AT 1:5 DILUTION MANUALLY ORDERED, WAS 7895 IU/ML WITH AN INVALIDATING DATA FLAG. THE SIXTH REPEAT RESULT FROM THE SECOND MODULE, WITH HE PATIENT SAMPLE AT 1:3 DILUTION MANUALLY ORDERED, WAS 3445 IU/ML WITH AN INVALIDATING DATA FLAG. THE SEVENTH REPEAT RESULT FROM THE SECOND MODULE, WITH THE PATIENT SAMPLE AT 1:3 DILUTION MANUALLY ORDERED, WAS 7926 IU/ML WITH AN INVALIDATING DATA FLAG. THE EIGHTH REPEAT RESULT FROM A PARTNER LABORATORY'S C 702 MODULE, WITH THE PATIENT SAMPLE UNDILUTED, WAS 257 IU/ML WITH
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 22307034 ↗
Other ANTISTREPTOLYSIN - TITER/STREPTOLYSIN O REAGENT devices
- Tina-quant Antistreptolysin O 5219191190Roche Diagnostics GmbH · ANTISTREPTOLYSIN - TITER/STREPTOLYSIN O REAGENT2 reports
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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