RAPID 20 E, REF 20701, System for the identification of Enterobacteriaceae in 4 hours, 25 strips/package, IVD.
Summary
The FDA issued a Class II for RAPID 20 E, REF 20701, System for the identification of Enterobacteriaceae in 4 by Biomerieux Inc. Reason: 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..
Details
Source
Device Recall
External ID
Z-0422-2022
Action Date
2022-01-05
Status
Terminated
Category
device
Product Description
RAPID 20 E, REF 20701, System for the identification of Enterobacteriaceae in 4 hours, 25 strips/package, IVD.
Lot/Code Info: Lot numbers 1008332150, Exp. 20-APR-2022, and 1008787180, Exp. 12-DEC-2022
Quantity Affected: 1,043 units
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.
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.
Type: Voluntary: Firm initiated
Recall Initiated: 2021-11-09
Company
Hazelwood, MO
Context & Analysis
This is a Class II recall. Class II recalls indicate that use of or exposure to the product may cause temporary or medically reversible health consequences, or that the probability of serious consequences is remote.
This was one of 90 device recalls issued in the same week, part of 413 device-related FDA actions this month.
Biomerieux Inc has 146 FDA actions in our database, including 122 recalls and 24 clearances.
Frequently Asked Questions
What is a Class II recall?
A Class II recall means the product may cause temporary or medically reversible adverse health consequences, or the probability of serious adverse consequences is remote. Consumers should discontinue use.
What should I do if I have this product?
Stop using the product. Check the product against the specific lot numbers or identifiers listed in the recall. Contact the manufacturer (Biomerieux Inc) or your retailer for a refund or replacement. If you experienced adverse effects, report them to the FDA via MedWatch.
How often does Biomerieux Inc have FDA actions?
Biomerieux Inc has 146 FDA actions in our database, including 122 recalls and 24 device clearances.
Where can I find the official FDA record?
The official record is available on FDA.gov. Search for "Z-0422-2022" on FDA.gov for the full record. You can also use the openFDA API to query this record programmatically.
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