CLASS II Device recall · Reported 11 Jul 2012 · FDA Enforcement Report

217 Osseo Avenue North, St. Cloud, MN Stain Control Slides recalled

Microbiologics is recalling 217 Osseo Avenue North, St. Cloud, MN Stain Control Slides, SLO3-10, ATCC Licensed, distributed nationwide in the US. The recall was initiated on 29 May 2012 and the FDA has classified it as Class II.

Check your package

Lot, batch or date codes0353 - 0355, 0357 - 0363

Quantity recalled13,720 slides (10 slides per box)

Stop using the device if the notice says to, and contact the manufacturer or your healthcare provider for the correction or replacement.

Recall details

Recall number: Z-1936-2012
FDA event ID: 61998
Recalling firm: Microbiologics, Saint Cloud, MN
Classification: Class II
Status: Terminated
Recall initiated: 29 May 2012
FDA classified: 3 Jul 2012
Reported: 11 Jul 2012
Type: Voluntary: Firm initiated
Customers notified by: Telephone
Reason category: E. coli
Device type: Other Medical Devices

Timeline

29 May 2012	Recall initiated by company
3 Jul 2012	Classified by FDA	+35 days
11 Jul 2012	Published in enforcement report	+8 days

Companies usually start a recall weeks before the FDA classifies and publishes it; the gap above is that lag.

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.

Some strains of E. coli, such as O157:H7, produce a toxin that can cause severe stomach cramps, bloody diarrhea and, in a small number of cases, kidney failure.

Product as listed by the FDA

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.

Where it was distributed

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.

Nationwide Arizona California Colorado Florida Georgia Iowa Illinois Kentucky Massachusetts Maine Michigan Minnesota Mississippi New Jersey New Mexico New York Pennsylvania Puerto Rico South Carolina Texas

Questions about this recall

Why was it recalled?

Which lots are affected?

0353 - 0355, 0357 - 0363

Where was it sold?

What should I do if I have it?

Stop using the device if the notice says to, and contact the manufacturer or your healthcare provider for the correction or replacement.

What does Class II mean?

Class II means the product may cause temporary or medically reversible health problems, or the probability of serious harm is remote.

Read the official FDA notice · Source record retrieved 26 Sep 2026. The FDA describes openFDA data as unvalidated; the official notice takes precedence. This page reports the record and gives no medical advice.

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