VITEK 2 Gram Positive Susceptibility Test Cards (AST-P605), REF 22 325. 20 Cards/Kit. bioMerieux, Inc, Durham, North Car

FDA device recall Z-1596-2016 · posted 2016-05-03 · Terminated

Recall details

Recalling firm

Biomerieux Inc

Reason for recall

Product may lead to false susceptible results of Staphylococcus spp., Enterococcus spp., and S. agalactiae to Minocycline.

Action taken

Biomerieux, Inc. sent an Urgent Notice Product Correction on February 24, 2016, to all affected customers. The recalling firm notified their foreign subsidiary of the Field Safety Corrective Action (FSCA) by email. The local subsidiary in the country impacted has informed users impacted and provided instructions to resolve the issue. Customers were instructed to confirm the Field Safety Corrective Action letter has been distributed and reviewed by all appropriate personnel within their organization. For the referenced test kit (VITEK 2 ASTP605, Lot 485368220), refrain from reporting Minocycline (MNO) results for any organism until a new lot is implemented in your laboratory. o Please note that a bioART rule can be created to suppress the analysis/reporting of Minocycline (reference VITEK 2 Online Software User Manual). The bioART rule can be disabled upon implementation of a new ASTP605 lot number. Customers were instructed tostore the letter with their bioMrieux instrument documentation. Complete the attached Acknowledgement Form and return it to their local bioMrieux representative. For questions regarding this recall call 314-731-8526.

Root cause

Other

Status

Terminated

Product code

LON

Quantity affected

337 Kits of 20 Cards/Kit

Distribution

Worldwide Distribution to China Taiwan region; No US/military/government distribution.

Date initiated

2016-02-24

Date posted

2016-05-03

Date terminated

2017-05-26

Location

Hazelwood, MO