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U.S. Department of Health and Human Services

Class 2 Device Recall ETEST ETP32 (Ertapenem)

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  Class 2 Device Recall ETEST ETP32 (Ertapenem) see related information
Date Initiated by Firm April 25, 2017
Date Posted May 03, 2017
Recall Status1 Terminated 3 on February 24, 2022
Recall Number Z-2095-2017
Recall Event ID 76983
510(K)Number K020748  
Product Classification Manual antimicrobial susceptibility test systems - Product Code JWY
Product ETEST ETP32 (Ertapenem) Ref. 531640, 531600, blister packaging
ETEST is a quantitative technique for determining the antimicrobial susceptibility of Gram-negative and Gram-positive aerobic bacteria

(Only 531640 was distributed in the United States)
Code Information REF 531640  Lot Number - 1003149850, 1003157690, 1003585350, 1003732380, 1003910410, 1004142070, 1004113370, 1004325260, 1004382730, 1004482780, 1004785720, 1004890160, 1005134380, 1005134390, 1005357180, 1005442470 --- REF 531600 - was not distributed in the United States
Recalling Firm/
Manufacturer
BioMerieux SA
Chemin De L'Orme
Marcy L'Etoile France
Manufacturer Reason
for Recall
False susceptible results
FDA Determined
Cause 2
Under Investigation by firm
Action bioMerieux sent an Urgent Product Safety Correction Notice on April 25, 2017 to U. S. consignees. The letter requested that they provide the notice to all appropriate personnel in the laboratory, asking them to identify any possible False Susceptible results. The letter included a Acknowledgment Form to be returned. On this notice the consignee will indicate the number of kits discarded. For customers with questions please contact their local bioMerieux Customer Service representative.
Quantity in Commerce 3,238 units
Distribution NATIONWIDE DISTRIBUTION TO AL, AZ, AR, CA, CO, CT, DE, DC, FL, GA, HI, IL, IN, IA, KS, KY, LA, M, MA, MD, MI, MN, MS, MO, MT, NE, NH, NJ, NY, NC, ND, OH, OK, OR, PA, RI, SC, SD, TN, TX, UT, VT, VA, WA, WV, WI, and 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.
510(K) Database 510(K)s with Product Code = JWY and Original Applicant = AB BIODISK
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