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BioFire RP2.1/RP2.1plus Control Panel M441

Mmqci · Model v.00 · UDI-DI 00852720008114

PMN
1
510(k) clearances
1
Adverse events
4
Recalls
10
Facilities

Description

External quality controls to monitor the performance of in vitro laboratory nucleic acid testing procedures for the FilmArray RP2.1/ RP2.1plus assay on the FilmArray 2.0/Torch systems.

Recalls

DateFirmReason
2019-05-16Microbiologics IncProduct is labeled with expiration date of 2021-10-31, should be 2021-03-31.
2019-04-09Microbiologics IncProduct with incorrect shelf life.
2019-04-09Microbiologics IncProduct with incorrect shelf life.
2019-01-31Microbiologics IncCepheid Xpert Respiratory Control Panel (Catalog #8199) has an reduced expiration date from 24 months to 13 months.

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Data 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.