Summary
The FDA issued a Class II for ETEST IMIPENEM RELEBACTAM. in vitro diagnostic by Biomerieux Inc. Reason: Major errors (Resistant result instead of Susceptible result) were observed with Pseudomonas aeruginosa strains..
Details
Source
Device Recall
External ID
Z-2226-2021
Action Date
2021-08-18
Status
Terminated
Category
device
Product Description
ETEST IMIPENEM RELEBACTAM. in vitro diagnostic
Lot/Code Info: 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
Quantity Affected: 1,431
Reason for Recall
Major errors (Resistant result instead of Susceptible result) were observed with Pseudomonas aeruginosa strains.
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.
Type: Voluntary: Firm initiated
Recall Initiated: 2021-06-24
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 183 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-2226-2021" on FDA.gov for the full record. You can also use the openFDA API to query this record programmatically.
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