CLASS II Device recall · Reported 3 Apr 2013 · FDA Enforcement Report
Kwik-qc Slides ( Kwik-qc Acid Fast Stain Slides recalled
Microbiologics is recalling Microbiologics Kwik-qc Slides ( Kwik-qc Acid Fast Stain Slides and Kwik-qc Mycobacterium, distributed in 7 states. The recall was initiated on 11 Feb 2013 and the FDA has classified it as Class II.
Check your package
Stop using the device if the notice says to, and contact the manufacturer or your healthcare provider for the correction or replacement.
Recall details
- Recall number
- Z-1021-2013
- FDA event ID
- 64469
- Recalling firm
- Microbiologics, Saint Cloud, MN
- Classification
- Class II
- Status
- Terminated
- Recall initiated
- 11 Feb 2013
- FDA classified
- 28 Mar 2013
- Reported
- 3 Apr 2013
- Type
- Voluntary: Firm initiated
- Customers notified by
- Letter
- Reason category
- Sterility
- Device type
- Test Kits & Diagnostics
Timeline
| 11 Feb 2013 | Recall initiated by company | |
| 28 Mar 2013 | Classified by FDA | +45 days |
| 3 Apr 2013 | Published in enforcement report | +6 days |
Companies usually start a recall weeks before the FDA classifies and publishes it; the gap above is that lag.
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
A sterility recall means a product that must be sterile, such as an injection or eye drop, may be contaminated. Using a non-sterile product can cause serious infection.
Product as listed by the FDA
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.
Where it was distributed
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.
CaliforniaIndianaMississippiNew YorkOhioPennsylvaniaSouth Dakota
Questions about this recall
Is Kwik-qc Slides ( Kwik-qc Acid Fast Stain Slides and Kwik-qc Mycobacterium Slides) recalled?
Yes. Microbiologics recalled Kwik-qc Slides ( Kwik-qc Acid Fast Stain Slides and Kwik-qc Mycobacterium Slides) on 11 Feb 2013. The recall is Class II and its status is Terminated. Recall number Z-1021-2013.
Why was it recalled?
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
Which lots are affected?
SL42-10 Lots 4239 to 4243 SL43-10 Lots 4333 to 4337
Where was it sold?
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.
What should I do if I have it?
Stop using the device if the notice says to, and contact the manufacturer or your healthcare provider for the correction or replacement.
What does Class II mean?
Class II means the product may cause temporary or medically reversible health problems, or the probability of serious harm is remote.
Read the official FDA notice · Source record retrieved 21 Sep 2026. The FDA describes openFDA data as unvalidated; the official notice takes precedence. This page reports the record and gives no medical advice.
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