Z-1936-2012Class II

Microbiologics 217 Osseo Avenue North, St. Cloud, MN 56303, Gram Stain Control Slides, SLO3-10, ATCC Licensed...

Name: Z-1936-2012 Microbiologics 217 Osseo Avenue North, St. Cloud, MN 56303, Gram Stain Control Slides, SLO3-10, ATCC Licensed...
Creator: Microbiologics Inc
Published: 2012-05-29
License: https://open.fda.gov/license/

Microbiologics, Inc. / initiated 2012-05-29 / Terminated / root cause: manufacturing process

FDA source

Microbiologics Inc began a recall of Microbiologics 217 Osseo Avenue North, St. Cloud, MN 56303, Gram Stain Control Slides, SLO3-10, ATCC Licensed Derivative, MediMart Europe, 11 rue Emile, Zola... on 2012-05-29. FDA classified it as Class II and gives the reason as "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...". As of 2026-09-10, the recall status on record is Terminated, and MDM tags the root cause as manufacturing process.

Recall record

Recall number: Z-1936-2012
Classification: Class II
Status: Terminated
Initiated: 2012-05-29
Posted: 2012-07-03
Terminated: 2013-01-08
Recalling firm: Microbiologics, Inc.
Product: 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 code: LJG Quality Control Slides
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.
Root cause tag: manufacturing process
FDA root cause: Nonconforming Material/Component
Action: Microbiologics sent an "URGENT MEDICAL DEVICE RECALL" letter dated May 30, 2012 to all affected customers. The letter identifies the product, problem, and actions to be taken by the customers. The letter instructs customers not to use or distribute the affected product and to quarantine and return to the firm any remaining product. A Customer Response Form was attached for customers to complete and return to the firm. Contact Customer Service at 320-229-7057 for questions regarding this recall.
Quantity in commerce: 13,720 slides (10 slides per box)
Distribution: 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.
Product codes and lots: 0353 - 0355, 0357 - 0363

Enforcement reports

One row per recalled product line

FDA enforcement reports joined to recall event Z-1936-2012
Recall number	Class	Status	Voluntary or mandated	Report date	Classified
Z-1936-2012	Class II	Terminated	Voluntary: Firm initiated	2012-07-11	2012-07-03

Product code LJG

The FDA recall record names no cleared device, and no clearance has been matched to it.

MDM coverage of this record lists here, newest first.

About this record

Sourced from the FDA device recall database and the FDA enforcement reports, both ingested from openFDA. The recall record supplies the product, the reason and the product code; the enforcement report supplies the classification. The two datasets are exported by FDA on different days, and the date above is the older of the two, so nothing on this page is newer than it says.

MDM adds the root cause tag, derived from FDA’s own root cause text, and the cross-links to the product code, the clearances named on the record and MDM coverage. Where a recall has not been joined to an enforcement report, no classification is shown.

Data as of 2026-09-30, the FDA export date for this dataset. Page last changed 2026-09-05. View this recall on fda.gov (opens on fda.gov)