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SPOTFIRE RSP Positive Control

Mmqci · Model v.00 · UDI-DI 00852720008091

510(k) clearances

Adverse events

Recalls

Facilities

Description

POS external qc to monitor the performance of in vitro laboratory nucleic acid testing procedures for the qualitative detection of pathogens included in BIOFIRE SPOTFIRE R Panel, BIOFIRE SPOTFIRE R Panel Mini and BIOFIRE SPOTFIRE R/ST Panel

Recalls

Date	Firm	Reason
2019-05-16	Microbiologics Inc	Product is labeled with expiration date of 2021-10-31, should be 2021-03-31.
2019-04-09	Microbiologics Inc	Product with incorrect shelf life.
2019-04-09	Microbiologics Inc	Product with incorrect shelf life.
2019-01-31	Microbiologics Inc	Cepheid 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.