FDA Device recall Z-1936-2012
Microbiologics 217 Osseo Avenue North, St. Cloud, MN 56303, Gram Stain Control Slides, SLO3-10, ATCC Licensed Derivative, MediMart Europe,…
- FDA Device
- Class II
- terminated
- Published 2012-07-11
On 2012-07-11 the FDA classified a Class II recall of Microbiologics 217 Osseo Avenue North, St. Cloud, MN 56303, Gram Stain Control Slides, SLO3-10, ATCC Licensed Derivative, MediMart Europe,… by Microbiologics, citing 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 cau….
Read the official FDA Device notice
| Agency | FDA Device |
|---|---|
| Recall number | Z-1936-2012 |
| Classification | Class II |
| Status | terminated |
| Initiated | 2012-05-29 |
| Published | 2012-07-11 |
| Last updated | 2026-09-13 11:53 UTC |
| Company | Microbiologics |
| Distribution | US |
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
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.
Identifiers
| code_info | 0353 - 0355, 0357 - 0363 |
|---|
Status history
No status changes recorded since RecallRadar first saw this recall on 2026-09-13 11:53 UTC. Current status: terminated.
Source
Official record: https://api.fda.gov/device/enforcement.json?search=recall_number:%22Z-1936-2012%22
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