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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 FirmFebruary 12, 2020
Create DateApril 09, 2020
Recall Status1 Terminated 3 on March 26, 2021
Recall NumberZ-1691-2020
Recall Event ID 85009
510(K)NumberK861022 
Product Classification Kit, quality control for culture media - Product Code JTR
ProductMicrobiologics QC SETS AND PANELS, YST Comprehensive QC Set, REF 5195P, containing Trichosporon dermatis, ATCC 204094, QR Code: (01)70845357030770, (17)200831, (10)5195-04.
Code Information Catalog Number: 5195P (KWIK-STIK kit that contains 0778P). Lot Numbers: 5195-04, 5195-05. UDI 70845357030770.
FEI Number 2150138
Recalling Firm/
Manufacturer		 Microbiologics Inc
200 Cooper Ave N
Saint Cloud MN 56303-4440
For Additional Information ContactKali Sorum
320-253-1640
Manufacturer Reason
for Recall		KWIKSTIK 2 Pack (REF 0778P) and QC Set and Panels: KWIKSTIK YST Comprehensive QC Set (REF 5195P) contain product labeled as Trichosporon dermatis (T. dermatis) which may contain Candida Utilis instead of T. dermatis.
FDA Determined
Cause 2		Nonconforming Material/Component
ActionMicrobiologics notified customer on 02/12/2020 via "Urgent Medical Device Correction" letter. The recall letter was emailed to consignees and the consignees were instructed to properly discard any affected products they have. The recall letter identified the affected product and lot numbers. Reason for the correction was also noted in the recall letter.
Quantity in Commerce49 units
DistributionNationwide, Including Australia, Brazil, Curacao, Ecuador, Germany, Greece, Italy, Puerto Rico, Singapore, Turkey, United States, Uruguay and Australia.
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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