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

FDA device recall Z-1936-2012 · posted 2012-07-03 · Terminated

Recall details

Recalling firm

Microbiologics Inc

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.

Action taken

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.

Root cause

Nonconforming Material/Component

Status

Terminated

Product code

LJG

Quantity affected

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, ISR

Date initiated

2012-05-29

Date posted

2012-07-03

Date terminated

2013-01-08

Location

Saint Cloud, MN