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HARDY DIAGNOSTICS · Model Z40 · UDI-DI 00819398026499

510(k) clearances

Adverse events

Recalls

Facilities

Description

Strep B Carrot Broth™ One-Step, 13x100mm Tube, 4ml Strep B Carrot Broth™ One-Step is a selective and differential medium which is intended for the detection of Group B Streptococcus (GBS) from anovaginal specimen collected from pregnant women. The medium is used as an aid in the qualitative determination of GBS colonization in pregnant women.

Recalls

Date	Firm	Reason
2022-11-09	Biomerieux Inc	As the temperature and time out of range was exceeded, product performances cannot be guaranteed
2020-10-06	Hardy Diagnostics	Streptococcus culture medium contains an incorrect expiration date. The culture medium outer box labeling contains an expiration date of 2021-11-10 instead of the correct expirat
2020-04-20	Cardinal Health Inc.	Three products requiring refrigerated storage conditions were incorrectly stored outside of approved temperature ranges. Using these temperature abused products may result in misdi

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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.