FDAFDA · Food and drugs·Recall number Z-1936-2012
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.
Published July 11, 2012 · Recall initiated: May 29, 2012
Status when published: Terminated — openFDA updates weekly, so this field may not reflect the current status. Always confirm with the official notice.
What's the hazard
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.
What to do
Voluntary: Firm initiated · Telephone
Recall details
- Manufacturer
- Microbiologics Inc
- Distributor
- Worldwide Distribution-USA (nationwide) including the states of AZ, CA, CO, FL, GA, IL, IA, KY, ME, MA, MI, MN, MS, NJ, NM, NY, PA, PR, SC, TX, VT, and VA. and the countries of SWITZERLAND, ITALY, ISRAEL, IRELAND, COLOMBIA, SWEDEN, INDIA, SINGAPORE, SERBIA, SAUDI ARABIA, CANADA, TAIWAN, SOUTH AFRICA, FRANCE, BRAZIL, MALTA, MACEDONIA, MALAYSIA, FINLAND, ECUADOR, VENEZUELA, REPUBLIC OF KOREA, NETHERLANDS, PERU, UNITED ARAB EMERITES, TURKEY, POLAND, and LEBANON.
- Lot
- 0353 - 0355, 0357 - 0363
- Risk classification
- Class II
- Area (FDA)
- device
- Country
- United States
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