Z-1936-2012 Class II Terminated

Recalled by Microbiologics Inc — Saint Cloud, MN

FDA device recall Z-1936-2012 was initiated by Microbiologics Inc on May 29, 2012 and is designated Class II. 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… The recall status is terminated (terminated Jan 8, 2013). Affected quantity: 13,720 slides (10 slides per box).

Recall Details

Product Type
Devices
Report Date
Jul 11, 2012
Initiation Date
May 29, 2012
Termination Date
Jan 8, 2013
Voluntary/Mandated
Voluntary: Firm initiated
Product Quantity
13,720 slides (10 slides per box)

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.

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.

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.

Code Information

0353 - 0355, 0357 - 0363

Source

Dataset
openFDA device recall enforcement reports
FDA record
This recall in openFDA (JSON)
Enforcement Report
Search FDA's Enforcement Report for Z-1936-2012
openFDA file date
Oct 23, 2026
Loaded by RegDataLab
Oct 26, 2026

These dates say when openFDA published the data file and when RegDataLab last loaded it.