FDA Medical Device Recalls (openFDA)
Microbiologics Inc: 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.
- Recall number
- Z-1021-2013
- Recalling firm
- Microbiologics Inc
- 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.
- Status
- Terminated
- Initiated
- 2013-02-11
- Posted
- 2013-03-28
- Terminated
- 2016-03-10
- Reason
- 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
- Root cause
- 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
- 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.
- Lot, serial or model codes
- SL42-10 Lots 4239 to 4243 SL43-10 Lots 4333 to 4337
- 510(k) numbers
- not on file
- PMA numbers
- not on file
- Product code
- LJG
- Firm FEI
- 2150138
- Firm city
- Saint Cloud
- Firm state
- MN
- Firm country
- not on file
Where this comes from
- Register
- FDA Medical Device Recalls (openFDA)
- Publisher
- U.S. Food and Drug Administration (openFDA)
- File
- device-recall-0001-of-0001.json.zip
- sha256
- b87518bfe2e8
- Size
- 288210821 bytes
- Published
- 2026-09-28
- Read
- 2026-09-29T08:25:23.626Z
- Source file
- Source file retained · verify
- Refresh due
- 2026-10-06
Unless otherwise noted, the content, data, documentation, code, and related materials on openFDA is public domain and made available with a Creative Commons CC0 1.0 Universal dedication.
Cite as
FDA Medical Device Recalls (openFDA) (U.S. Food and Drug Administration (openFDA)), device-recall-0001-of-0001.json.zip, sha256 b87518bfe2e8, published 2026-09-28