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Simplexa™ Flu A/B & RSV Positive Control Pack
DIASORIN MOLECULAR LLC · Model MOL2660 · UDI-DI 20816101025552
OCC
Prescription
10
510(k) clearances
808
Adverse events (9 deaths)
25
Recalls
33
Facilities
Recalls
| Date | Firm | Reason |
|---|---|---|
| 2025-04-30 | BioFire Diagnostics, LLC | Due to manufacturing error, respiratory panel may result in elevated control failures and/or false negative results. |
| 2025-03-04 | Abbott Diagnostics Scarborough, Inc. | the impacted lots have a higher occurrence of invalid rates when compared to the product Instructions for Use. |
| 2025-03-04 | Abbott Diagnostics Scarborough, Inc. | The impacted lots have a higher occurrence of invalid rates when compared to the product Instructions for Use. |
| 2024-09-05 | Luminex Molecular Diagnostics Inc | Respiratory pathogen panel may report an elevated rate (7.6% predicted probability of occurrence) of non-specific hMPV target (human Metapneumovirus) results, risk identified pred |
| 2024-08-07 | BioFire Diagnostics, LLC | Some automated in vitro diagnostic modules and instruments manufactured or serviced between May 2022 and May 2024 were calibrated with internal equipment that may lead modules and |
| 2023-01-30 | DiaSorin Molecular LLC | Direct amplification Discs , used with COVID-19 and Flu A/B & RSV assays, may leak and cause contamination, cross-contamination, invalid results, and error codes. |
| 2020-10-30 | Luminex Corporation | Potential for a false-negative result. |
| 2020-10-30 | Luminex Corporation | Potential for a false-negative result. |
| 2020-10-30 | Luminex Corporation | Potential for a false-negative result. |
| 2020-10-30 | Luminex Corporation | Potential for a false-negative result. |
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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.