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U.S. Department of Health and Human Services

Class 2 Device Recall Microbiologics KWIKQC SLIDES

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 Class 2 Recall
Microbiologics KWIKQC SLIDES
see related information
Date Posted March 28, 2013
Recall Status1 Open
Recall Number Z-1021-2013
Recall Event ID 64469
Product Classification Quality Control Slides - Product Code LJG
Product Microbiologics KWIK-QC SLIDES ( KWIK-QC Acid Fast Stain Slides and KWIK-QC Mycobacterium Slides). Slide preparations serving as quality control challenges to demonstrate satisfactory performance of staining reagents.
Code Information SL42-10 Lots 4239 to 4243 SL43-10 Lots 4333 to 4337
Recalling Firm/
Manufacturer
Microbiologics Inc
200 Cooper Avenue North
Saint Cloud, Minnesota 56303-4452
Consumer Instructions Contact the recalling firm for information
Manufacturer Reason
for Recall
Microbiologics Inc is initiating a voluntary recall on products KWIK-QC Acid Fast Stain Slide, SL42-10 and KWIK-QC Mycobacterium, SL43-10. These products are being recalled because the control organisms are not properly fixated on the slide, which may cause the user to unintentionally contaminate the patient area of the slide by flooding the control well with stain. This contamination could pote
FDA Determined
Cause 2
DESIGN: Device Design
Action Microbiologists an "Urgent Medical Device Recall" letter dated February 11, 2013. The Letter described the product and the reason for the recall. Advised consignees to "Do not Distribute" and "Return" the product. Urged consignees to "Notify" end users and to complete the attached "Recall Response Form". Contact the form at 320-229-7057 for questions regarding this notice.
Quantity in Commerce 396 boxes of 10 slides each.
Distribution Worldwide Distribution-USA including the states of CA, IN, MS, NY, OH, PA, and SD, and the countries of AUSTRALIA, AUSTRIA, UNITED ARAB EMIRATES, MALAYSIA, TAIWAN, JAPAN, TURKEY, BELGIUM, COLOMBIA, CANADA, SOUTH AFRICA, and VENEZUELA.
Total Product Life Cycle TPLC Device Report

 
1 For details about termination of a recall see Code of Federal Regulations (CFR) Title 21 §7.55
2 Per FDA policy, recall cause determinations are subject to modification up to the point of termination of the recall.
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