Microbiologics Inc: Medical Device Recall in 2013 - (Recall #: Z-1021-2013)

Updated on March 25, 2026.

See the recall detail below. You can also see other recalls from the same firm in 2013.

Data Source: FDA.

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.

Product Classification:

Class II

Date Initiated: February 11, 2013

Date Posted: April 3, 2013

Recall Number: Z-1021-2013

Event ID: 64469

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

Status: Terminated

Product Quantity: 396 boxes of 10 slides each.

Code Information:

SL42-10 Lots 4239 to 4243 SL43-10 Lots 4333 to 4337

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.

Voluntary or Mandated:

Voluntary: Firm initiated