Z-1596-2016Class II

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

Name: Z-1596-2016 VITEK 2 Gram Positive Susceptibility Test Cards (AST-P605), REF 22 325. 20 Cards/Kit. bioMerieux, Inc...
Creator: Biomerieux Inc
Published: 2016-02-24
License: https://open.fda.gov/license/

bioMerieux, Inc. / initiated 2016-02-24 / Terminated

FDA source

Biomerieux Inc began a recall of 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... on 2016-02-24. FDA classified it as Class II and gives the reason as "Product may lead to false susceptible results of Staphylococcus spp., Enterococcus spp., and S. agalactiae to Minocycline". As of 2026-09-10, the recall status on record is Terminated.

Recall record

Recall number: Z-1596-2016
Classification: Class II
Status: Terminated
Initiated: 2016-02-24
Posted: 2016-05-03
Terminated: 2017-05-26
Recalling firm: bioMerieux, Inc.
Product: 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.
Product code: LON System, Test, Automated, Antimicrobial Susceptibility, Short Incubation
Reason for recall: Product may lead to false susceptible results of Staphylococcus spp., Enterococcus spp., and S. agalactiae to Minocycline.
FDA root cause: Other
Action: 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.
Quantity in commerce: 337 Kits of 20 Cards/Kit
Distribution: Worldwide Distribution to China Taiwan region; No US/military/government distribution.
Product codes and lots: Lot/Serial: 485368220 Expiry: 12-JAN-17

Enforcement reports

One row per recalled product line

FDA enforcement reports joined to recall event Z-1596-2016
Recall number	Class	Status	Voluntary or mandated	Report date	Classified
Z-1596-2016	Class II	Terminated	Voluntary: Firm initiated	2016-05-11	2016-05-03

Product code LON

The FDA recall record names no cleared device, and no clearance has been matched to it.

MDM coverage of this record lists here, newest first.

About this record

Sourced from the FDA device recall database and the FDA enforcement reports, both ingested from openFDA. The recall record supplies the product, the reason and the product code; the enforcement report supplies the classification. The two datasets are exported by FDA on different days, and the date above is the older of the two, so nothing on this page is newer than it says.

MDM adds the root cause tag, derived from FDA’s own root cause text, and the cross-links to the product code, the clearances named on the record and MDM coverage. Where a recall has not been joined to an enforcement report, no classification is shown.

Data as of 2026-10-14, the FDA export date for this dataset. Page last changed 2026-09-05. View this recall on fda.gov (opens on fda.gov)