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HARDY DIAGNOSTICS · Model Z61 · UDI-DI 00819398027212
10
510(k) clearances
211
Adverse events
21
Recalls
26
Facilities
Description
Bile Spot Test, Deoxycholate 10%, for Streptococcus pneumoniae, rapid spot test for pneumococci, 15ml each Sodium desoxycholate 10%, use to identify S. pneumoniae, colonies will autolyze in the presence of bile salts. Store in refrigerator, warm before use. Recommended for use in presumptively differentiating bile soluble Streptococcus pneumoniae from bile insoluble alpha-hemolytic Streptococcus spp. The bile solubility test may be performed using a cell suspension or by applying the Bile Spot Reagent directly to the colony.
Recalls
| Date | Firm | Reason |
|---|---|---|
| 2022-11-09 | Biomerieux Inc | As the temperature and time out of range was exceeded, product performances cannot be guaranteed |
| 2022-11-09 | Biomerieux Inc | As the temperature and time out of range was exceeded, product performances cannot be guaranteed |
| 2022-11-09 | Biomerieux Inc | As the temperature and time out of range was exceeded, product performances cannot be guaranteed |
| 2022-11-09 | Biomerieux Inc | As the temperature and time out of range was exceeded, product performances cannot be guaranteed |
| 2022-11-09 | Biomerieux Inc | As the temperature and time out of range was exceeded, product performances cannot be guaranteed |
| 2022-11-09 | Biomerieux Inc | As the temperature and time out of range was exceeded, product performances cannot be guaranteed |
| 2022-11-09 | Biomerieux Inc | As the temperature and time out of range was exceeded, product performances cannot be guaranteed |
| 2022-11-09 | Biomerieux Inc | As the temperature and time out of range was exceeded, product performances cannot be guaranteed |
| 2022-11-09 | Biomerieux Inc | As the temperature and time out of range was exceeded, product performances cannot be guaranteed |
| 2022-11-09 | Biomerieux Inc | As the temperature and time out of range was exceeded, product performances cannot be guaranteed |
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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.