Z-1021-2013 Class II Terminated
FDA device recall Z-1021-2013 was initiated by Microbiologics Inc on Feb 11, 2013 and is designated Class II. 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… The recall status is terminated (terminated Mar 10, 2016). Affected quantity: 396 boxes of 10 slides each.
Recall Details
- Product Type
- Devices
- Report Date
- Apr 3, 2013
- Initiation Date
- Feb 11, 2013
- Termination Date
- Mar 10, 2016
- Voluntary/Mandated
- Voluntary: Firm initiated
- Product Quantity
- 396 boxes of 10 slides each.
Product Description
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.
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
Distribution Pattern
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.
Code Information
SL42-10 Lots 4239 to 4243 SL43-10 Lots 4333 to 4337
Source
- Dataset
- openFDA device recall enforcement reports
- FDA record
- This recall in openFDA (JSON)
- Enforcement Report
- Search FDA's Enforcement Report for Z-1021-2013
- openFDA file date
- Oct 23, 2026
- Loaded by RegDataLab
- Oct 26, 2026