Microbiologics KWIK-QC SLIDES — Class II medical device recall Z-1021-2013
Terminated recall by Microbiologics Inc, reported 2013-04-03, distributed in CA, IN, MS, NY, OH, PA, SD. Microbiologics Inc is initiating a voluntary recall on products KWIK-QC Acid Fast Stain Slide, SL42-10 and KWI
| Recall number | Z-1021-2013 |
|---|---|
| Product type | Medical device |
| Classification | Class II |
| Status | Terminated |
| Voluntary or mandated | Voluntary |
| Recalling firm | Microbiologics Inc, Saint Cloud, MN, United States |
| Recall initiated | 2013-02-11 |
| Classified | 2013-03-28 |
| Reported by FDA | 2013-04-03 |
| Terminated | 2016-03-10 |
| Distributed | CA, IN, MS, NY, OH, PA, SD |
| Countries outside the US | AE, AT, AU, BE, CA, CO, JP, MY, TR, TW, VE, ZA |
| Reason classes | microbial contamination |
| Lot numbers | 4239, 4243, 4333, 4337, SL43-10 |
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.
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
Machine access
This record, with every extracted code, the verbatim FDA record and provenance, is available from the recall API: GET https://api.data.aroqon.com/v1/recalls/Z-1021-2013. Look up any UPC, UDI, NDC or lot with /v1/recalls/lookup?code=…. API docs · free and paid keys.
Source: U.S. Food and Drug Administration enforcement report via openFDA (CC0). Structured by Data Foundry (recall-structuring@2); last changed 2026-09-26. Not affiliated with or endorsed by FDA. Not medical or legal advice.