FDAFDA · Food and drugs·Recall number Z-1021-2013
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.
Published April 3, 2013 · Recall initiated: February 11, 2013
Status when published: Terminated — openFDA updates weekly, so this field may not reflect the current status. Always confirm with the official notice.
What's the hazard
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
What to do
Voluntary: Firm initiated · Letter
Recall details
- Manufacturer
- Microbiologics Inc
- Distributor
- 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.
- Lot
- SL42-10 Lots 4239 to 4243 SL43-10 Lots 4333 to 4337
- Risk classification
- Class II
- Area (FDA)
- device
- Country
- United States
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