Z-2874-2018Class II

bioMrieux VITEK 2 NH ID Test Kit

Name: Z-2874-2018 bioMrieux VITEK 2 NH ID Test Kit
Creator: Biomerieux Inc
Published: 2018-01-23
License: https://open.fda.gov/license/

bioMerieux, Inc. / initiated 2018-01-23 / Terminated / root cause: manufacturing process

FDA source

Biomerieux Inc began a recall of bioMrieux VITEK 2 NH ID Test Kit Product Usage: Is an automated system consisting of instruments, software and reagent cards designed for the ID and... on 2018-01-23. FDA classified it as Class II and gives the reason as "Missing desiccant". As of 2026-09-10, the recall status on record is Terminated, and MDM tags the root cause as manufacturing process.

Recall record

Recall number: Z-2874-2018
Classification: Class II
Status: Terminated
Initiated: 2018-01-23
Posted: 2018-08-17
Terminated: 2021-07-13
Recalling firm: bioMerieux, Inc.
Product: bioMrieux VITEK 2 NH ID Test Kit Product Usage: Is an automated system consisting of instruments, software and reagent cards designed for the ID and antimicrobial susceptibility testing of bacteria and yeast.
Product code: JST Kit, Fastidious Organisms
Reason for recall: Missing desiccant.
Root cause tag: manufacturing process
FDA root cause: Nonconforming Material/Component
Action: bioMrieux sent to customers letter requesting the following actions; - Please confirm this letter has been distributed and reviewed by all appropriate personnel within your organization. - Please dispose of any VITEK 2 NH ID test kits, Lot 2450570403, in your stock that were received prior to 25-JAN-2018 and do not have a blue sticker on the carton. Please contact your local bioMrieux representative for replacement of destroyed test kits. - Please store this letter with your bioMrieux VITEK 2 System documentation. - Complete the attached Acknowledgement Form and return it to your local bioMrieux representative. bioMrieux, Inc. is committed to providing our customers with the highest quality products, and we apologize for any inconvenience this has caused your business. If you have any questions or concerns, please contact your local bioMrieux representative.
Quantity in commerce: 57 cartons
Distribution: US Nationwide Distribution in the states of AK, AL, AR, AZ, CA, CO, DC, FL, GA, IA, IL, IN, KS, KY, LA, MA, MD, MI, MN, MO, MS, MT, NC, ND, NH, NJ, NY, OH, OK, OR, PA, SC, TN, TX, UT. VA. VT. WA. WI, and WV
Product codes and lots: Batch/Lot: 245057043 Exp. Date 19JUN2019

Enforcement reports

One row per recalled product line

FDA enforcement reports joined to recall event Z-2874-2018
Recall number	Class	Status	Voluntary or mandated	Report date	Classified
Z-2874-2018	Class II	Terminated	Voluntary: Firm initiated	2018-08-29	2018-08-17

Product code JST

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 2026-09-30, the FDA export date for this dataset. Page last changed 2026-09-05. View this recall on fda.gov (opens on fda.gov)