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HARDY DIAGNOSTICS · Model SP57 · UDI-DI 00816576027262
10
510(k) clearances
3,143
Adverse events
2
Recalls
17
Facilities
Description
Middlebrook 7H11 Thin Pour, for microscopic examination, 10x100mm Space Saver plate, order by the package of 15 For the isolation and detection of mycobacteria using the microcolony method. Thin pour plate for microscopic examination. Use with MycoSeals (cat. no. SS9225)
Recalls
| Date | Firm | Reason |
|---|---|---|
| 2009-02-19 | Becton Dickinson & Co. | In vitro diagnostic test reagent may contain residual material that inhibits the growth of gram positive/gram negative organisms. |
| 2004-09-27 | Remel, Inc. | The product does not perform as intended with some quality control organisms (Haemophilus influenzae) |
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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.