Reported Jul 11, 2012 · Terminated
Microbiologics 217 Osseo Avenue North, St. Cloud, MN 56303, Gram Stain Control Slides, SLO3-10, ATCC Licensed…
Microbiologics Inc.
Moderate riskThis product could cause temporary or reversible health problems — stop using it.What you should do
Stop using the affected lot and contact the recalling firm for the return or refund process. Check the FDA enforcement report for lot-level detail.
Firm contact: Microbiologics Inc · 217 Osseo Ave N · Saint Cloud, MN · 56303-4452
Is this the product you have?
- 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.
- Lot codes and dates
0353 - 03550357 - 0363
- Amount recalled
- 13,720 slides (10 slides per box)
Where it was sold
Why it was recalled
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.
This product could cause temporary or reversible health problems — stop using it.
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