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cobas liat Bordetella panel control kit
Roche Molecular Systems, Inc. · Model 09857672190 · UDI-DI 00875197007367
OZZ
Prescription
1
510(k) clearances
0
Adverse events
2
Recalls
13
Facilities
Recalls
| Date | Firm | Reason |
|---|---|---|
| 2025-03-24 | Ortho-Clinical Diagnostics, Inc. | It was determined that there could be a false positive rate of up to 16.7% for the affected lots associated with the Bordetella parapertussis (BPP) results (only) of the assay. |
| 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 |
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