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FilmArray Pneumonia/Pneumoniaplus Control

Mmqci · Model v.00 · UDI-DI 00852720008022

PMN
10
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 Pneumonia Panel or Pneumonia Panel plus assay on the FilmArray 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.