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U.S. Department of Health and Human Services

Class 2 Device Recall bioMerieux RAPID 20 E

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  Class 2 Device Recall bioMerieux RAPID 20 E see related information
Date Initiated by Firm November 09, 2021
Create Date December 27, 2021
Recall Status1 Open3, Classified
Recall Number Z-0422-2022
Recall Event ID 89041
Product Classification Kit, identification, enterobacteriaceae - Product Code JSS
Product RAPID 20 E, REF 20701, System for the identification of Enterobacteriaceae in 4 hours, 25 strips/package, IVD.
Code Information Lot numbers 1008332150, Exp. 20-APR-2022, and 1008787180, Exp. 12-DEC-2022
Recalling Firm/
Manufacturer		 Biomerieux Inc
595 Anglum Rd
Hazelwood MO 63042-2320
For Additional Information Contact Clinical Customer Support
800-682-2666
Manufacturer Reason
for Recall		 There is an error in the new version of the package insert. The Reading Table lists the incorrect color for a negative result for the CIT test.
FDA Determined
Cause 2		 Under Investigation by firm
Action bioMerieux in the U.S. issued an Urgent Field Safety Notice dated November 2021 on 11/9/2021 via email for delivery to the Lab Director or Lab Manager. The notice described the issue, impact to the customer, and listed the required customer actions: Distribute the information to all appropriate personnel in their laboratory and forward the information to all parties that may use the product, including others to whom the product may have been transferred. The customer is informed they can continue to use RAPID 20 E, however, they must refer to the following Reading Table or to the corrected RAPID 20 E package insert version "G1" available on Resource Center when reading the CIT test result. For tests previously performed using RAPID 20 E, the customer is strongly recommended that they identify any possible misidentifications to analyze the related risks and to determine appropriate actions, if relevant. An Acknowledgement Form was enclosed to confirm receipt of the notice.
Quantity in Commerce 1,043 units
Distribution US Nationwide distribution in the states of AL, AZ, CA, CO, CT, DE, FL, GA, IA, ID, IL, IN, KS, KY, MA, MI, MO, NC, NE, NJ, NY, OH, OK, PA, RI, SC, SD, TX, VA, WA, and WI. There was government distribution but no military distribution.
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 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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