Microbiologics Inc: Medical Device Recall in 2012 - (Recall #: Z-1936-2012)

Updated on March 25, 2026.

See the recall detail below. You can also see other recalls from the same firm in 2012.

Data Source: FDA.

Product Description:

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.

Product Classification:

Class II

Date Initiated: May 29, 2012

Date Posted: July 11, 2012

Recall Number: Z-1936-2012

Event ID: 61998

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.

Status: Terminated

Product Quantity: 13,720 slides (10 slides per box)

Code Information:

0353 - 0355, 0357 - 0363

Distribution Pattern:

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.

Voluntary or Mandated:

Voluntary: Firm initiated