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Kit, Fastidious Organisms

FDA product code JST · Class 1 · Microbiology

3
Registered devices
24
Adverse events
6
Recalls
6
510(k) clearances

Devices with this code

VITEK® 2 NH — BIOMERIEUX , INC.BD BBL™ Crystal™ Identification Systems — BECTON, DICKINSON AND COMPANYBD BBL™ Crystal™ N/H — BECTON, DICKINSON AND COMPANY

Recent 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
2018-03-23BioMerieux SAA shipment to Guadeloupe suffered a temperature excursions up to 47.8C, exceeding the acceptable limits. After detection of the issue, Global Supply Chain QA as
2018-01-23Biomerieux IncMissing desiccant.
2017-04-20Biomerieux IncThe integrity of the product container may be compromised thereby exposing product to moisture which could lead to antibiotic degradation (loss of potency).

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Sourced from public U.S. FDA data. Informational only — not medical or regulatory advice. Not affiliated with the FDA.