Quick Links: Skip to main page content Skip to Search Skip to Topics Menu Skip to Common Links
  • Decrease font size
  • Return font size to normal
  • Increase font size
U.S. Department of Health and Human Services

Class 2 Device Recall bioMrieux VITEK 2 NH ID Test Kit

  • Print
  • Share
  • E-mail
-
Super Search Devices@FDA
510(k) | DeNovo | Registration & Listing | Adverse Events | Recalls | PMA | HDE | Classification | Standards
CFR Title 21 | Radiation-Emitting Products | X-Ray Assembler | Medsun Reports | CLIA | TPLC
 


New Search Back to Search Results
 Class 2 Device Recall bioMrieux VITEK 2 NH ID Test Kitsee related information
Date Initiated by FirmJanuary 23, 2018
Create DateAugust 17, 2018
Recall Status1 Terminated 3 on July 13, 2021
Recall NumberZ-2874-2018
Recall Event ID 80491
Product Classification Kit, fastidious organisms - Product Code JST
ProductbioMrieux 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.
Code Information Batch/Lot: 245057043 Exp. Date 19JUN2019
FEI Number 1950204
Recalling Firm/
Manufacturer		 Biomerieux Inc
595 Anglum Rd
Hazelwood MO 63042-2320
For Additional Information ContactContact your Local Representative
800-682-2666
Manufacturer Reason
for Recall		Missing desiccant.
FDA Determined
Cause 2		Nonconforming Material/Component
ActionbioMrieux 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
DistributionUS 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
Total Product Life CycleTPLC Device Report
1 A record in this database is created when a firm initiates a correction or removal action. The record is updated if the FDA identifies a violation and classifies the action as a recall, and it is updated for a final time when the recall is terminated. Learn more about medical device recalls.
2 Per FDA policy, recall cause determinations are subject to modification up to the point of termination of the recall.
3 For details about termination of a recall see Code of Federal Regulations (CFR) Title 21 §7.55.
-
-