Microbiologics 217 Osseo Avenue North — Class II medical device recall Z-1936-2012
Terminated recall by Microbiologics Inc, reported 2012-07-11, distributed nationwide. Microbiologics is recalling a number of lots of KWIK-QC Gram Stain Slides. This product gram negative control
| Recall number | Z-1936-2012 |
|---|---|
| Product type | Medical device |
| Classification | Class II |
| Status | Terminated |
| Voluntary or mandated | Voluntary |
| Recalling firm | Microbiologics Inc, Saint Cloud, MN, United States |
| Recall initiated | 2012-05-29 |
| Classified | 2012-07-03 |
| Reported by FDA | 2012-07-11 |
| Terminated | 2013-01-08 |
| Distributed | Nationwide (US) |
| Countries outside the US | BR, CA, CH, CO, EC, FI, FR, IE, IL, IN, IT, KR, LB, MT, MY, NL, PE, PL, RS, SA, SE, SG, TR, TW, VE, ZA |
| Reason classes | microbial contamination |
| Pathogens | e coli |
Product
Microbiologics 217 Osseo Avenue North, St. Cloud, MN 56303, Gram Stain Control Slides, SLO3-10, ATCC Licensed Derivative, MediMart Europe, 11 rue Emile, Zola B.P. 2332, 38933 Grenoble Cedex 2 France. They are microscope slide preparations contains specific organisms populations of known and predictable characteristics. These slide support formal quality assurance programs by serving as quality control challenges to demonstrate and document satisfactory performance of staining regents and methods used in staining procedures and to document personnel's ability to perform the procedure and to properly interpret the microscopic test results.
Reason for recall
Microbiologics is recalling a number of lots of KWIK-QC Gram Stain Slides. This product gram negative control organism (E.coli) is 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 potentially lead to misdiagnosis and improper treatment of a patient.
Machine access
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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.