Devices

Device Recall VITEK 2 Gram Positive Susceptibility Test Cards ASTP605 REF 22 325

Model / Serial
Lot/Serial: 485368220 Expiry: 12-JAN-17
Product Classification
Immunology and Microbiology Devices
Device Class
2
Implanted device?
No
Distribution
Worldwide Distribution to China Taiwan region; No US/military/government distribution.
Product Description
VITEK 2 Gram Positive Susceptibility Test Cards (AST-P605), REF 22 325. 20 Cards/Kit. bioMerieux, Inc, Durham, North Carolina 27712. || VITEK 2 is an automated system consisting of instruments, software, and reagent cards designed for the identification and antimicrobial susceptibility testing of bacteria and yeast. The VITEK 2 utilizes growth-based biochemical patterns to determine identification. The VITEK 2 provides minimal inhibitory concentration (MIC) results for most organism/drug combinations as well as a category interpretation (S, I, or R) consistent with accepted criteria. The VITEK 2 System is not considered a life supporting/sustaining device and does not deliver any type of energy or substance to the patient. The VITEK 2 Gram Positive Susceptibility Card is intended for use with the VITEK 2 Systems in clinical laboratories as an in vitro test to determine the susceptibility of Staphylococcus spp., Enterococcus spp., and S. agalactiae to antimicrobial agents when used as instructed in the Product Information manual.
Manufacturer
Biomerieux Inc
1 Event
- Recall of Device Recall VITEK 2 Gram Positive Susceptibility Test Cards ASTP605 REF 22 325

Manufacturer

Biomerieux Inc

Manufacturer Address
Biomerieux Inc, 595 Anglum Rd, Hazelwood MO 63042-2320
Manufacturer Parent Company (2017)
Compagnie Merieux Alliance
Source
USFDA

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