KWIK-STIK, Quality control kit for culture media, sold as: a. KWIK-STIK 2-pack Enterococcus faecalis derived from AT
Summary
The FDA issued a Class II for KWIK-STIK, Quality control kit for culture media, sold as: a. KWIK-STIK 2-pa by Microbiologics Inc. Reason: Tests returning incorrect susceptible results. High Level Gentamicin Synergy value was out of specification (sensitive) when analyzed on the Vitek 2 .
Details
Source
Device Recall
External ID
Z-0585-2022
Action Date
2022-02-16
Status
Terminated
Category
device
Product Description
KWIK-STIK, Quality control kit for culture media, sold as: a. KWIK-STIK 2-pack Enterococcus faecalis derived from ATCC 51299 b. KWIK-STIK 6-pack Enterococcus faecalis derived from ATCC 51299
Lot/Code Info: a. Catalog Number 0959P, UDI: 20845357023210, Lot Number (Expiration Date): 959-94-3 (04/30/2020), 959-95-2 (09/30/2020), 959-96-1 (12/31/2020), 959-96-4 (12/31/2021), 959-97-4 (03/31/2021), 959-97-5 (03/31/2021); b. Catalog Number 0959K, UDI: 30845357023224, Lot Number (Expiration Date): 959-94-2 (04/30/2020), 959-95-1 (09/30/2020), 959-95-5 (09/30/2020), 959-96-3 (12/31/2020), 959-97-1 (03/31/2021), 959-97-6 (03/31/2021);
Quantity Affected: 1,975 units
Reason for Recall
Tests returning incorrect susceptible results. High Level Gentamicin Synergy value was out of specification (sensitive) when analyzed on the Vitek 2 AST-GP67 card, and these lots failed the disk diffusion method used for product release.
Distribution
Worldwide Distribution. US nationwide including Puerto Rico and Guam, Australia, Austria, Belgium, Brazil, Canada, Chile, China, Colombia, Costa Rica, Croatia/Hrvatska, Curacao, Denmark, Ecuador, Egypt, El Salvador, Finland, France, Germany, Guatemala, Hong Kong, India, Ireland, Israel, Italy, Japan, Democratic People's Republic of Korea, Republic of Korea, Kuwait, Lebanon, Malaysia, Netherlands, New Zealand, Panama, Peru, Poland, Portugal, Qatar, Romania, Saudi Arabia, Singapore, South Africa, Spain, Sweden, Switzerland, Taiwan, Thailand, Trinidad and Tobago, Turkey, United Arab Emirates, United Kingdom, and Vietnam.
Type: Voluntary: Firm initiated
Recall Initiated: 2020-02-18
Company
Saint Cloud, MN
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 154 device recalls issued in the same week, part of 403 device-related FDA actions this month.
Microbiologics Inc has 52 FDA actions in our database, including 52 recalls.
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 (Microbiologics Inc) or your retailer for a refund or replacement. If you experienced adverse effects, report them to the FDA via MedWatch.
How often does Microbiologics Inc have FDA actions?
Microbiologics Inc has 52 FDA actions in our database, including 52 recalls and 0 device clearances.
Where can I find the official FDA record?
The official record is available on FDA.gov. Search for "Z-0585-2022" on FDA.gov for the full record. You can also use the openFDA API to query this record programmatically.
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