KWIK-STIK, Quality control kit for culture media, sold as: KWIK-STIK (single-pack) Enterococcus faecalis derived fro
Summary
The FDA issued a Class II for KWIK-STIK, Quality control kit for culture media, sold as: KWIK-STIK (single by Microbiologics Inc. Reason: This strain should be resistant to high levels of Gentamicin and be resistant to Gentamicin Synergy. A specific lot was found susceptible to Gentamici.
Details
Source
Device Recall
External ID
Z-0714-2022
Action Date
2022-03-09
Status
Terminated
Category
device
Product Description
KWIK-STIK, Quality control kit for culture media, sold as: KWIK-STIK (single-pack) Enterococcus faecalis derived from ATCC 51299
Lot/Code Info: Catalog Number HL163263 OEM Private Label with Healthlink; UDI: N/A (OEM agreement with Healthlink ended in Q1 2016 before UDI was required for class 1 IVDs) Lot Number (Expiration Date): 959-74-1 (10/08/2014), 959-75-2 (04/22/2015), 959-75-3 (04/22/2015), 959-75-6 (04/22/2015), 959-75-7 (04/22/2015), 959-75-10 (04/22/2015), and 959-76-2 (07/08/2015)
Quantity Affected: 150 units
Reason for Recall
This strain should be resistant to high levels of Gentamicin and be resistant to Gentamicin Synergy. A specific lot was found susceptible to Gentamicin Synergy during in-house testing.
Distribution
Worldwide distribution - US Nationwide and the countries of Argentina, Belgium, Brazil, Canada, Chile, China, Colombia, Croatia/Hrvatska, Ecuador, Finland, France, Germany, Guam, Guatemala, Hong Kong, India, Ireland, Israel, Italy, Japan, Kenya, Republic of Korea, Latvia, Macedonia, Malaysia, Netherlands, Panama, Peru, Poland, Portugal, Puerto Rico, Romania, Saudi Arabia, Singapore, South Africa, Switzerland, Taiwan, Tanzania, Thailand, Turkey, Uganda, United Arab Emirates, and Vietnam.
Type: Voluntary: Firm initiated
Recall Initiated: 2014-10-06
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 130 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-0714-2022" on FDA.gov for the full record. You can also use the openFDA API to query this record programmatically.
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