KWIK-STIK, Enterobacter cloacae subsp. cloacae derived from ATCC 13047, REF 0323P. Packaged 2 units per pack. IVD cont
Summary
The FDA issued a Class III for KWIK-STIK, Enterobacter cloacae subsp. cloacae derived from ATCC 13047, REF 0323 by Microbiologics Inc. Reason: Potential of products packaged for lot 323-108-7 were packaged in pouches labeled as 726-57-10..
Details
Source
Device Recall
External ID
Z-0544-2022
Action Date
2022-02-09
Status
Terminated
Category
device
Product Description
KWIK-STIK, Enterobacter cloacae subsp. cloacae derived from ATCC 13047, REF 0323P. Packaged 2 units per pack. IVD controls.
Lot/Code Info: Catalog Number: 0323P, Lot Number: 323-108-7, UDI: 20845357006381
Quantity Affected: 47 packs (94 units)
Reason for Recall
Potential of products packaged for lot 323-108-7 were packaged in pouches labeled as 726-57-10.
Distribution
US distribution to CA, FL, HI, MI, NC, NH, NJ, OK, OR, TN. International distribution to Canada, Ecuador, France, India, Indonesia, Ireland, Japan, Mexico, South Africa, United Arab Emirates, Vietnam.
Type: Voluntary: Firm initiated
Recall Initiated: 2021-02-24
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 95 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-0544-2022" on FDA.gov for the full record. You can also use the openFDA API to query this record programmatically.
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