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HARDY DIAGNOSTICS · Model W25 · UDI-DI 00816576027491

JSJ
10
510(k) clearances
535
Adverse events
6
Recalls
24
Facilities

Description

Inhibitory Mold Agar (with chloramphenicol), deep fill, 15x100mm plate, order by the package of 10 For the selective isolation of pathogenic fungi. Contains chloramphenicol for inhibition of bacteria.

Recalls

DateFirmReason
2026-02-05Remel, IncCustomer complaints report low to no recovery of Campylobacter Jejuni ATCC 33291 on identified lot of medium.
2018-08-02Acumedia Manufacturers, Inc.The product is labeled with an incorrect expiration date.
2016-03-21Hardy DiagnosticsPerformance failure; poor hemolytic reaction of non or weakly hemolytic group B streptococcus (GBS) with the target QC organism, Streptococcus agalactiae (ATCC 13813) due to produc
2013-06-06Becton Dickinson & Co.Microbiological identification media may exhibit reduced levels of Vancomycin.
2013-06-06Becton Dickinson & Co.Microbiological identification media may exhibit reduced levels of Vancomycin.
2013-06-06Becton Dickinson & Co.Microbiological identification media may exhibit reduced levels of Vancomycin.

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Data 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.