FDASeptember 23, 2021device
SIMPLEXA COVID-19 Positive Control Pack, REF MOL4160, IVD, Rx Only, UDI: (01) 20816101027051
Official recall recorded by the U.S. Food & Drug Administration.
The hazard
Due to unapproved raw materials used in the manufacturing of Covid-19 control pack, their is the potential for delayed amplification signals.
What to do
FDA enforcement status: Ongoing
Brands named
diasorin moleculardiasorin
UPCs
20816101027051
Recall history
Other federal recalls tied to the same brand — a factual pattern, straight from the source data.
- FDAAlinity m Resp-4-Plex Amplification (AMP) Kit (CE), List Number 09N79-090, a multiplex real-time reverse transcription (RT) polymerase chain reaction (PCR) test intended for the qualitative detection and differentiation of RNA from influenza A virus (flu A), influenza B virus (flu B), Respiratory...2025-04-28
- FDAAlinity m Resp-4-Plex AMP Kit, List Number 09N79-096, a multiplex real-time reverse transcription (RT) polymerase chain reaction (PCR) test intended for the simultaneous qualitative detection and differentiation of RNA from SARS-CoV-2, influenza A virus (flu A), influenza B virus (flu B), and/or ...2025-04-28
- FDAThe Alinity m System is designed to automate the steps for nucleic acid testing. Model Numbers included in this recall are 08N53-001, 08N53-002, and 08N53-032 (Refurbished).2025-03-20
- FDADiaSorin LIAISON Q.S.E.T. Device Plus, REF 319060; intended for use in the preparation of human stool specimens2024-11-07
- FDAAbbott Alinity m HPV AMP Kit, used with the Alinity m System, product codes: a) REF 09N15-095; b) REF 09N15-090; c) REF 09N15-0912024-09-12
- FDAAbbott Alinity m STI AMP Kit, used with the Alinity m System, product codes: a) REF 09N17-095; b) REF 09N17-090; c) REF 09N17-091;2024-09-12
- FDANxTAG Respiratory Pathogen Panel +SARS-CoV-2, REF: I056C04682024-09-05
- FDANxTAG Respiratory Pathogen Panel, REF: I051C04472024-09-05
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