KWIK-STIK(TM), Quality control kit for culture media, sold as: KWIK-STIK(TM) 2-pack Enterococcus faecalis derived fr
Summary
The FDA issued a Class III for KWIK-STIK(TM), Quality control kit for culture media, sold as: KWIK-STIK(TM) by Microbiologics Inc. Reason: Some of the KWIK-STIK Catalog #01023P Campylobacter coli, Lot# 1023-05-7, contained an inner label stating the product is Catalog #0919K Haemophilus i.
Details
Source
Device Recall
External ID
Z-0641-2022
Action Date
2022-02-23
Status
Terminated
Category
device
Product Description
KWIK-STIK(TM), Quality control kit for culture media, sold as: KWIK-STIK(TM) 2-pack Enterococcus faecalis derived from ATCC(R) 51299(TM)
Lot/Code Info: Catalog Number 01023P, UDI: 20845357029502, Lot Number (Expiration Date): 1023-05-7 (04/30/2014)
Quantity Affected: 10 units
Reason for Recall
Some of the KWIK-STIK Catalog #01023P Campylobacter coli, Lot# 1023-05-7, contained an inner label stating the product is Catalog #0919K Haemophilus influenza. The organism has been confirmed to be C. coli, indicating this is a labeling error and the organism is the correct organism.
Distribution
Worldwide distribution - US Nationwide and the countries of Canada, South Africa, France, Netherlands, Mauritius, China.
Type: Voluntary: Firm initiated
Recall Initiated: 2013-03-25
Company
Saint Cloud, MN
Context & Analysis
This is a Class III recall. Class III recalls involve products unlikely to cause adverse health consequences, but that violate FDA regulations.
This was one of 164 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 III recall?
A Class III recall involves products that are unlikely to cause adverse health effects but violate FDA labeling or manufacturing regulations.
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-0641-2022" on FDA.gov for the full record. You can also use the openFDA API to query this record programmatically.
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