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HARDY DIAGNOSTICS · Model Z68 · UDI-DI 00819398027441

JTO
10
510(k) clearances
211
Adverse events
21
Recalls
27
Facilities

Description

Lactophenol Cotton Blue, fungal stain, 15ml For the staining of fungi in slide wetmounts. See also BlueMount (Cat no. Z137)

Recalls

DateFirmReason
2022-11-09Biomerieux IncAs the temperature and time out of range was exceeded, product performances cannot be guaranteed
2022-11-09Biomerieux IncAs the temperature and time out of range was exceeded, product performances cannot be guaranteed
2022-11-09Biomerieux IncAs the temperature and time out of range was exceeded, product performances cannot be guaranteed
2022-11-09Biomerieux IncAs the temperature and time out of range was exceeded, product performances cannot be guaranteed
2022-11-09Biomerieux IncAs the temperature and time out of range was exceeded, product performances cannot be guaranteed
2022-11-09Biomerieux IncAs the temperature and time out of range was exceeded, product performances cannot be guaranteed
2022-11-09Biomerieux IncAs the temperature and time out of range was exceeded, product performances cannot be guaranteed
2022-11-09Biomerieux IncAs the temperature and time out of range was exceeded, product performances cannot be guaranteed
2022-11-09Biomerieux IncAs the temperature and time out of range was exceeded, product performances cannot be guaranteed
2022-11-09Biomerieux IncAs the temperature and time out of range was exceeded, product performances cannot be guaranteed

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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.