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PRAS Thioglycollate Broth (THIO)

ANAEROBE SYSTEMS · Model AS-805 · UDI-DI 00810048900596

JSC
10
510(k) clearances
78
Adverse events
5
Recalls
15
Facilities

Description

AS-805 Thioglycollate Broth (THIO) is an enriched nonselective liquid medium used for the growth of microaerophilic and anaerobic bacteria, including fastidious organisms, from clinical specimens. Pre-reduced anaerobically sterilized (PRAS). 5 mL fill volume. 16 x 100 mm hungate-capped tube. Transparent light yellow liquid with a marble chip. 10 tubes per pack.

Recalls

DateFirmReason
2021-09-30bioMerieux, Inc.There is potential to provide an incorrect organism identification.
2015-11-18Hardy DiagnosticsThe firm is recalling FB Broth Cat. no. K31, Lot no. 15231 because of potential Burkholderia fungorum contamination.
2012-12-10Becton Dickinson & Co.Enrichment media intended to enhance the cultivation of various microorganisms may fail to support the growth of Haemophilus species.
2012-02-20Becton Dickinson & Co.In vitro diagnostic reagent is defective and may fail to enhance the growth of microbiological cultures as intended.
2009-12-21Remel, IncProduct failure - Failure to grow quality control strains of Streptococcus pneumoniae.

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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.