Z-1021-2013Class II

Microbiologics KWIK-QC SLIDES ( KWIK-QC Acid Fast Stain Slides and KWIK-QC Mycobacterium Slides). Slide...

Name: Z-1021-2013 Microbiologics KWIK-QC SLIDES ( KWIK-QC Acid Fast Stain Slides and KWIK-QC Mycobacterium Slides). Slide...
Creator: Microbiologics Inc
Published: 2013-02-11
License: https://open.fda.gov/license/

Microbiologics, Inc. / initiated 2013-02-11 / Terminated / root cause: design

FDA source

Microbiologics Inc began a recall of Microbiologics KWIK-QC SLIDES ( KWIK-QC Acid Fast Stain Slides and KWIK-QC Mycobacterium Slides). Slide preparations serving as quality control challenges to... on 2013-02-11. FDA classified it as Class II and gives the reason as "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...". As of 2026-09-10, the recall status on record is Terminated, and MDM tags the root cause as design.

Recall record

Recall number: Z-1021-2013
Classification: Class II
Status: Terminated
Initiated: 2013-02-11
Posted: 2013-03-28
Terminated: 2016-03-10
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.
Product code: LJG Quality Control Slides
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
Root cause tag: design
FDA 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 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.
Product codes and lots: SL42-10 Lots 4239 to 4243 SL43-10 Lots 4333 to 4337

Enforcement reports

One row per recalled product line

FDA enforcement reports joined to recall event Z-1021-2013
Recall number	Class	Status	Voluntary or mandated	Report date	Classified
Z-1021-2013	Class II	Terminated	Voluntary: Firm initiated	2013-04-03	2013-03-28

Product code LJG

The FDA recall record names no cleared device, and no clearance has been matched to it.

MDM coverage of this record lists here, newest first.

About this record

Sourced from the FDA device recall database and the FDA enforcement reports, both ingested from openFDA. The recall record supplies the product, the reason and the product code; the enforcement report supplies the classification. The two datasets are exported by FDA on different days, and the date above is the older of the two, so nothing on this page is newer than it says.

MDM adds the root cause tag, derived from FDA’s own root cause text, and the cross-links to the product code, the clearances named on the record and MDM coverage. Where a recall has not been joined to an enforcement report, no classification is shown.

Data as of 2026-09-30, the FDA export date for this dataset. Page last changed 2026-09-05. View this recall on fda.gov (opens on fda.gov)