Home › HARDY DIAGNOSTICS › Carrot Broth™
Carrot Broth™
HARDY DIAGNOSTICS · Model Z140T · UDI-DI 10819398020579
4
510(k) clearances
4
Adverse events
3
Recalls
3
Facilities
Description
Strep B Carrot Broth™ Tiles, for the selective enrichment and identification of beta-hemolytic group B streptococci (S. agalactiae) from clinical specimens. Tiles must be added to broth (not included) upon inoculation.
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 |
Query this across every FDA database — by API.
Linked GUDID · 510(k)/PMA · MAUDE · recalls · establishments. Free tier, no card required.
Get your free API keyRead the docsData 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.