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U.S. Department of Health and Human Services

Class 3 Device Recall KWIKSTIK

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 Class 3 Device Recall KWIKSTIKsee related information
Date Initiated by FirmFebruary 24, 2021
Date PostedJanuary 31, 2022
Recall Status1 Terminated 3 on July 11, 2022
Recall NumberZ-0544-2022
Recall Event ID 89380
510(K)NumberK861022 
Product Classification Kit, quality control for culture media - Product Code JTR
ProductKWIK-STIK, Enterobacter cloacae subsp. cloacae derived from ATCC 13047, REF 0323P. Packaged 2 units per pack. IVD controls.
Code Information Catalog Number: 0323P,  Lot Number: 323-108-7,  UDI: 20845357006381
Recalling Firm/
Manufacturer		 Microbiologics Inc
200 Cooper Ave N
Saint Cloud MN 56303-4440
For Additional Information ContactBecky Neu
320-229-7073
Manufacturer Reason
for Recall		Potential of products packaged for lot 323-108-7 were packaged in pouches labeled as 726-57-10.
FDA Determined
Cause 2		Labeling mix-ups
ActionMicrobiologics notified customers on about 02/24/2021 via letter titled "Urgent Medical Device Recall." Instructions included to inspect inventory for affected products. If found, instructions were to: 1. REVIEW lab procedures to understand how this information affects your usage; 2. USE OR DISCARD depending on your lab procedures and how this information affects your usage; 3.COMPLETE the response form provided; 4. RETURN the response form to recall@microbiologics.com; 5. KEEP this letter for your records; 6. CONTACT Microbiologics if a replacement kit is needed. Questions or concerns can be directed to Recall Support team at 320.229.7073 or recall@microbiologics.com.
Quantity in Commerce47 packs (94 units)
DistributionUS 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.
Total Product Life CycleTPLC Device Report
1 A record in this database is created when a firm initiates a correction or removal action. The record is updated if the FDA identifies a violation and classifies the action as a recall, and it is updated for a final time when the recall is terminated. Learn more about medical device recalls.
2 Per FDA policy, recall cause determinations are subject to modification up to the point of termination of the recall.
3 For details about termination of a recall see Code of Federal Regulations (CFR) Title 21 §7.55.
510(K) Database510(K)s with Product Code = JTR
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