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Class 3 Device Recall KWIKSTIK |
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Date Initiated by Firm |
February 24, 2021 |
Date Posted |
January 31, 2022 |
Recall Status1 |
Terminated 3 on July 11, 2022 |
Recall Number |
Z-0544-2022 |
Recall Event ID |
89380 |
510(K)Number |
K861022
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Product Classification |
Kit, quality control for culture media - Product Code JTR
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Product |
KWIK-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
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For Additional Information Contact |
Becky Neu 320-229-7073
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Manufacturer Reason for Recall |
Potential of products packaged for lot 323-108-7 were packaged in pouches labeled as 726-57-10.
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FDA Determined Cause 2 |
Labeling mix-ups |
Action |
Microbiologics 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 Commerce |
47 packs (94 units) |
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. |
Total Product Life Cycle |
TPLC Device Report
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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.
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510(K) Database |
510(K)s with Product Code = JTR and Original Applicant = MICRO-BIO-LOGICS
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