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PRAS Brucella Agar Deep CLSI Formulation 17mL (BRU DEEP CLSI 17mL)
ANAEROBE SYSTEMS · Model AS-809 · UDI-DI 00810048901388
10
510(k) clearances
879
Adverse events
29
Recalls
65
Facilities
Description
AS-809 Brucella Agar Deep CLSI 17 mL (BRU DEEP CLSI 17mL), with the addition of blood, is intended for the isolation, quantitation, and partial identification of obligate anaerobic bacteria from clinical specimens. This media will support the growth of aerobic and microaerophilic bacteria if incubated appropriately. Pre-reduced anaerobically sterilized (PRAS). 17 mL fill volume. 20 x 113 mm screw top tube. Translucent yellow. 10 tubes per pack.
Recalls
| Date | Firm | Reason |
|---|---|---|
| 2025-04-24 | Mckesson Medical-Surgical Inc. Corporate Office | transit delays of certain cold chain products due to severe thunderstorms which may caused the products to be stored outside the recommended labeled storage conditions. This failur |
| 2021-02-16 | Vectornate USA Inc | Discoloration and turbidity were present in the specified lots of STMs because of Longer Monsoon season at the South Korean Manufacturing Facility. |
| 2019-04-17 | Remel Inc | Potential for products to fail performance testing per the Instructions for Use (IFU) starting at 57 days after date of manufacturing. Expiration date is shortened from 7 months t |
| 2019-04-17 | Remel Inc | Potential for products to fail performance testing per the Instructions for Use (IFU) starting at 106 days after date of manufacturing. Expiration date is shortened from 9 months t |
| 2019-04-17 | Remel Inc | Potential for products to fail performance testing per the Instructions for Use (IFU) starting at 106 days after date of manufacturing. Expiration date is shortened from 9 months t |
| 2019-04-17 | Remel Inc | Potential for products to fail performance testing per the Instructions for Use (IFU) starting at 106 days after date of manufacturing. Expiration date is shortened from 9 months t |
| 2019-04-17 | Remel Inc | Potential for products to fail performance testing per the Instructions for Use (IFU) starting at 57 days after date of manufacturing. Expiration date is shortened from 7 months t |
| 2019-04-17 | Remel Inc | Potential for products to fail performance testing per the Instructions for Use (IFU) starting at 106 days after date of manufacturing. Expiration date is shortened from 9 months t |
| 2019-04-17 | Remel Inc | Potential for products to fail performance testing per the Instructions for Use (IFU) starting at 106 days after date of manufacturing. Expiration date is shortened from 9 months t |
| 2019-04-17 | Remel Inc | Potential for products to fail performance testing per the Instructions for Use (IFU) starting at 106 days after date of manufacturing. Expiration date is shortened from 9 months t |
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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.