Tinaquant 2Microglobulin 11660551216Recalls & reported problems
Roche Diagnostics GmbH · Class 2
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 04015630900152), received between Apr 25, 2019 and Apr 25, 2019 — 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.
Most reported problems
Device problems
- Low Test Results1
Patient problems
- No Known Impact Or Consequence To Patient1
Recent adverse event reports
The 1 most recent of 1 reports, in the reporter's own words as published by the FDA.
MalfunctionApr 25, 2019Low Test Results; Low Test Results
THIS REPORT SUMMARIZES <NOE>1</NOE> MALFUNCTION EVENTS. ERRONEOUS LOW RESULTS WERE GENERATED BY A COBAS 6000 C (501) MODULE. THE EVENTS INVOLVED 1 PATIENT WITH DISCREPANT RESULTS FOR B2MG TINA-QUANT BETA2-MICROGLOBULIN. THE PROVIDED PATIENT'S AGE WAS (B)(6). THE PATIENT WAS A FEMALE.
Patient problems: No Known Impact Or Consequence To Patient
MAUDE report 8551517 ↗
Other SYSTEM, TEST, BETA-2-MICROGLOBULIN IMMUNOLOGICAL devices
- Atellica CH B2M 11097635Siemens Healthcare Diagnostics Inc. · System, test, beta-2-microglobulin immunological2 recalls0 reports
- Optilite Beta 2 Microglobulin Urine Kit LK043.L.OPT.AThe Binding Site Group Limited · System, Test, Beta-2-Microglobulin Immunological1 recall0 reports
- Tina-quant ß2-Microglobulin 08047430190Roche Diagnostics GmbH · System, test, beta-2-microglobulin immunological1 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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