Z-2295-2010

VITEK TWO AST-N085 REF 22 225 For In Vitro Diagnostic Use - each test card is packaged into a foil pouch with...

Name: Z-2295-2010 VITEK TWO AST-N085 REF 22 225 For In Vitro Diagnostic Use - each test card is packaged into a foil pouch with...
Creator: Biomerieux Inc
Published: 2010-07-29
License: https://open.fda.gov/license/

bioMerieux, Inc. / initiated 2010-07-29 / Terminated / root cause: packaging

FDA source

Biomerieux Inc began a recall of VITEK TWO AST-N085 REF 22 225 For In Vitro Diagnostic Use - each test card is packaged into a foil pouch with 20 pouches per box. The firm name on the label is... on 2010-07-29. The reason FDA records is "Foil pouch was punctured by drug susceptibility cards during packaging, allowing moisture into pouch, resulting in inaccurate and/or incorrect drug susceptibility results". As of 2026-09-10, the recall status on record is Terminated, and MDM tags the root cause as packaging.

Recall record

Recall number: Z-2295-2010
Status: Terminated
Initiated: 2010-07-29
Posted: 2010-08-27
Terminated: 2010-11-02
Recalling firm: bioMerieux, Inc.
Product: VITEK TWO AST-N085 REF 22 225 For In Vitro Diagnostic Use - each test card is packaged into a foil pouch with 20 pouches per box. The firm name on the label is bioMerieux, Inc., Durham, NC and bioMerieux, sa, France.This is an Export Only test kit that is not marketed in the U.S.
Product code: LON System, Test, Automated, Antimicrobial Susceptibility, Short Incubation
Reason for recall: Foil pouch was punctured by drug susceptibility cards during packaging, allowing moisture into pouch, resulting in inaccurate and/or incorrect drug susceptibility results.
Root cause tag: packaging
FDA root cause: Packaging
Action: BioMerieux issued an Urgent Product Removal Notice, dated July 29, 2010 to consignees, identifying the reason for the recall and the affected lots. Customers were instructed to discontinue use of and destroy any remaining inventory of the affected lot, and to notify their customers who received the product. All consignees were instructed to complete and return the Customer Acknowledgement and Product Replacement Form. These cards will be used to distribute replacement cards. Consignees can contact BioMerieux at 1-314- 731-8667.
Quantity in commerce: 1297/ 20 card boxes
Distribution: Worldwide Distribution: Country of Canada only. No product was distributed in the US.
Product codes and lots: Lot number 345158910 Exp:2011/04/21

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 2026-10-07, the FDA export date for this dataset. Page last changed 2026-09-05. View this recall on fda.gov (opens on fda.gov)