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HARDY DIAGNOSTICS · Model L225 · UDI-DI 00819398022132
10
510(k) clearances
181
Adverse events
2
Recalls
30
Facilities
Description
EnteroScreen 4™, for Salmonella and Shigella screening, 11ml, 16x125mm tube, 4 layer slant, order by the package of 20 For the screening of enteric pathogens and the differentiation of Salmonella and Shigella from stool specimens and to rule out normal enteric flora. With this method, urease activity, lysine-decarboxylase, lysine-deaminase, gas production, and hydrogen sulfide production reactions can be simultaneously evaluated; all from one tube! Invented by Dr. Gary Procop of the Cleveland Clinic. See technical insert for color ID chart
Recalls
| Date | Firm | Reason |
|---|---|---|
| 2025-07-11 | Remel, Inc | The products may contain surface and subsurface contamination of Listeria monocytogenes. |
| 2017-03-24 | Remel Inc | Confirmed complaint of surface contamination of Listeria monocytogenes. |
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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.