| Class 2 Device Recall ETEST IMIPENEM RELEBACTAM | |
Date Initiated by Firm | June 24, 2021 |
Create Date | August 06, 2021 |
Recall Status1 |
Open3, Classified |
Recall Number | Z-2226-2021 |
Recall Event ID |
88242 |
510(K)Number | K191953 |
Product Classification |
Manual antimicrobial susceptibility test systems - Product Code JWY
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Product | ETEST IMIPENEM RELEBACTAM. in vitro diagnostic |
Code Information |
Ref 420927 (US Product) Lot numbers 1007888860, 1008598340, 1008701580, 1007607290, 1007888870, 1008390030, 1008598350 and 1008701590 and Ref 420925 (not distributed in US):Lot Codes: 1007888860, 100859840 and 1008701580 |
Recalling Firm/ Manufacturer |
Biomerieux Inc 595 Anglum Rd Hazelwood MO 63042-2320
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For Additional Information Contact | Clinical Customer Support 800-682-2666 |
Manufacturer Reason for Recall | Major errors (Resistant result instead of Susceptible result) were observed with Pseudomonas aeruginosa strains. |
FDA Determined Cause 2 | Under Investigation by firm |
Action | The recall notification was issued to the impacted subsidiaries and distributors on 24JUN2021. The notification includes a Customer Letter to be translated into local language and sent to each impacted customer.
The customer letter will inform the customers about the MIC overestimation and false resistant results issue and will be instructed to:
- Perform a retest using an alternative method on P. aeruginosa strains for which they obtained resistant or intermediate results with ETEST IMIPENEM RELEBACTAM ref. 420925 and 420927
- Among tests previously performed, identify any possible false resistant/intermediate results that may have occurred, to analyze the related risks and to determine appropriate actions if relevant. |
Quantity in Commerce | 1,431 |
Distribution | Worldwide distribution - US Nationwide distribution including in the states of AR, AZ, CA, CO, DE, FL, GA, IL, IN, KS, KY, MA, MD, ME, MI, MN, MO, NC, NE, NH, NJ, NV, NY, OH, OK, PA, SC, TN, TX, UT, VA, WA, WI, WV and Hawaii. The countries of
Austria, Belgium, Croatia, Czech Republic, France, Germany, Greece, Italy, Netherlands, Poland, Portugal, Spain, Sweden, Switzerland and United Kingdom. |
Total Product Life Cycle | TPLC Device Report |
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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 The manufacturer has initiated the recall and not all products have been corrected or removed. This record will be updated as the status changes.
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510(K) Database | 510(K)s with Product Code = JWY
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