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U.S. Department of Health and Human Services

Class 2 Device Recall KWIKSTIK

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 Class 2 Device Recall KWIKSTIKsee related information
Date Initiated by FirmOctober 08, 2020
Create DateOctober 27, 2020
Recall Status1 Terminated 3 on November 17, 2022
Recall NumberZ-0303-2021
Recall Event ID 86576
510(K)NumberK861022 
Product Classification Kit, quality control for culture media - Product Code JTR
Product Each KWIK-STIK unit contains a lyophilized microorganism pellet, an ampoule of hydrating fluid, and an inoculating swab. Each device is sealed within a laminated pouch that contains a desiccant to prevent adverse moisture accumulation. KWIK-STIK microorganisms are 3 passages or fewer from the reference culture and are guaranteed to recover when processed using the recommended media and incubation requirements. Available in packs of 2 or 6.
Code Information Catalog 01145K, Lot 1145-06-5  UDI: 30845357036811
FEI Number 2150138
Recalling Firm/
Manufacturer		 Microbiologics Inc
200 Cooper Ave N
Saint Cloud MN 56303-4440
For Additional Information ContactEmily Dunaisky
320-253-1640
Manufacturer Reason
for Recall		KWIK-STIK 6 Pack Klebsiella pneumoniae derived from NCTC 13443 (Catalog# 01145K) should contain the NDM-1 positive strain, but was confirmed to be NDM-1 negative.
FDA Determined
Cause 2		Under Investigation by firm
ActionThe recalling firm is sending consignees recall notification letters beginning 10/08/2020 via email. The correction communication was first extended to the first level of the distribution change (those who received product directly from Microbiologics). Distributors outside of the US will be contacted via email, and if follow up is necessary, the recalling firm's international sales team will work with each distributor to ensure this communication is extended to their end users. The recalling firm is working with its European Authorized Representative to coordinate this field safety corrective action in the EU.
Quantity in Commerce1 unit
DistributionDistribution in US, Brazil, Canada, Costa Rica, France, Germany, Ireland, Italy, Japan, New Zealand, Sweden, and United Kingdom.
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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