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HARDY DIAGNOSTICS · Model X95 · UDI-DI 00819398024563
10
510(k) clearances
19
Adverse events
6
Recalls
15
Facilities
Description
Middlebrook ADC Supplement, 20ml, 1 ounce bottle, order by the package of 10 For use as a supplement for Middlebrook media.
Recalls
| Date | Firm | Reason |
|---|---|---|
| 2015-09-11 | Acumedia Manufacturers, Inc. | Incorrect expiration date on label. Correct expiration date was March 25, 2019. Product was labeled with expiration date of March 28,2019. |
| 2015-02-05 | Remel Inc | Use of the product may not provide adequate recovery and could result in false negative identification of Legionella pneumophila. |
| 2014-11-13 | Remel Inc | Use of the product could result in inadequate recovery of Legionella pneumophila which could result in false negative reporting. |
| 2014-10-17 | Remel Inc | Recalled product may not provide adequate recovery of Legionella pneumophila when used as directed and may result in false negative identification of Legionella pneumophila. |
| 2014-01-24 | Remel Inc | The product may contain high levels of microbial contamination |
| 2012-10-10 | Remel Inc | The product may contain low level microbial contamination which could result in incorrect results. |
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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.