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cobas Liat Strep A Script Version 1.27
Roche Molecular Systems, Inc. · Model 08403856001 · UDI-DI 07613336156544
PGX
Prescription
10
510(k) clearances
3
Adverse events (1 deaths)
4
Recalls
17
Facilities
Recalls
| Date | Firm | Reason |
|---|---|---|
| 2023-04-24 | Cepheid | pipettes packaged in Strep A test may fail to dispense an adequate sample volume which could result in "invalid" results or no result test results. |
| 2023-04-24 | Cepheid | pipettes packaged in Strep A test may fail to dispense an adequate sample volume which could result in "invalid" results or no result test results. |
| 2019-02-20 | Luminex Corporation | Through internal investigation, it was discovered that a portion of side cassette assemblies (SCAs) back side seal (BSS) did not meet design specification, resulting in partially |
| 2016-02-10 | Focus Diagnostics Inc | Focus Diagnostics is recalling the Direct Amplification Discs (DAD) supplied with the Simplexa HSV 1 & 2 Direct (MOL2150), Simplexa Flu A/B & RSV Direct (MOL2650) and Simplexa Grou |
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Get your free API keyRead the docsData compiled from public U.S. FDA sources (GUDID, 510(k)/PMA, MAUDE, recalls, establishment registration). Adverse-event reports are unverified and do not establish causation. Informational only — not medical, clinical, or regulatory advice.