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U.S. Department of Health and Human Services

Class 2 Device Recall API ZYM B (Ref 70493)

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  Class 2 Device Recall API ZYM B (Ref 70493) see related information
Date Initiated by Firm January 08, 2016
Date Posted February 04, 2016
Recall Status1 Terminated 3 on July 14, 2017
Recall Number Z-0756-2016
Recall Event ID 73060
Product Classification Device, general purpose, microbiology, diagnostic - Product Code LIB
Product API ZYM Bx2 (Ref 70493)

Product Usage:
ZYM B reagent is an additional test used for revealing the results of some miniaturized biochemical test including in the involved API strips.
Code Information Lot No. PF - 1003765610/Lot No. Ampules - 1003693040/Exp. date 1/15/16 Lot No. PF - 1003772410/Lot No. Ampules - 1003711170/Exp. date 1/19/16 Lot No. PF - 1003772470/Lot No. Ampules - 1003733320/Exp. date 1/29/16 Lot No. PF - 1003787970/Lot No. Ampules - 1003693020/Exp. date 1/12/16 Lot No. PF - 1003790030/Lot No. Ampules - 1003790010/Exp. date 2/26/16 Lot No. PF - 1004077210/Lot No. Ampules - 1004024590/Exp. date 5/25/16 Lot No. PF - 1004097610/Lot No. Ampules - 1004040410/Exp. date 6/2/16 Lot No. PF - 1004355410/Lot No. Ampules - 1004306800/Exp. date 9/20/16 Lot No. PF - 1004355730/Lot No. Ampules - 1004306790/Exp. date 9/20/16
Recalling Firm/
Manufacturer		 BioMerieux SA
Chemin De L'Orme
Marcy L'Etoile France
For Additional Information Contact Ryan LeMelle
314-731-8582
Manufacturer Reason
for Recall		 Discrepant identification results related to API identification strips. These discrepant identification results are due to false negative results on the tests of the strips linked to the ZYM B reagent.
FDA Determined
Cause 2		 Other
Action BioM¿rieux sent an Urgent Field Safety Notice letter DATED jANUARY 8, 2015 to affected customers. The letter identified the affected product, problem and action to be taken. dated . The letter indicated that they could continue to use product in inventory with mandatory requirements that before using a ZYM B ampule and each day of use of API strips that they perform a quality control with ATCC strains as described in each package insert of involved API strips. The letter also requested that they distribute this letter to all appropriate personnel in the laboratory, retain a copy for their files, and forward the information to all parties that may use the product. For additional assistance or have any questions, contact your local bioM¿rieux Customer Service representative.
Quantity in Commerce 13,271
Distribution Nationwide Distribution in the states of: AL, CA, CO, CT, DC, FL, GA, HI, IL, IN, IA, KS, KY, ME, MD, MA, MI, MN, MS, MO, NV, NH, NJ, NM, NY, NC, ND, OH, OK, OR, PA, RI, SC, SD, TX, VT, VA, WA, WV, WI, WY
Total Product Life Cycle TPLC 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.
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