Microbiologics Recalls KWIK-QC Gram Stain Slides Due to Fixation Defect
Microbiologics is recalling KWIK-QC Gram Stain Slides because the control organism is not properly fixated, which may lead to slide contamination and potential patient misdiagnosis.
The agency’s classification
FDA (Devices): Class II
Class II is a situation in which use of or exposure to a violative product may cause temporary or medically reversible adverse health consequences, or where the probability of serious adverse health consequences is remote.
This is the agency’s own classification, taken from its notice. The severity score below is our assessment, not the agency’s. How recall classes work
What this means for you
Our assessment, not the agency’s: severity 3/5 (High).
Real risk of harm even if no illness or injury has been reported yet. Stop using the product and follow the agency's guidance.
Our severity reasoning: The recall is classified as FDA Class II. The hazard involves a risk of patient misdiagnosis and improper treatment due to potential contamination, which fits the 'High' severity criteria for risk-of-harm products where injury has not yet been reported.
Plain-English summary
Microbiologics is recalling specific lots of KWIK-QC Gram Stain Slides. The recall involves 13,720 slides, distributed in boxes of 10. The affected lots have codes ranging from 0353 to 0355 and 0357 to 0363.
The recall is being issued because the gram-negative control organism (E. coli) on the slides is not properly fixated. This defect may cause users to unintentionally contaminate the patient area of the slide by flooding the control well with stain. Such contamination could potentially lead to misdiagnosis and improper treatment of a patient.
The product was distributed worldwide, including nationwide in the United States and in numerous international countries. Users should stop using the affected slides and contact Microbiologics for further instructions.
The recalled product
- 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…
- Manufacturer
- Microbiologics Inc
Is your product affected?
Check your packaging against the codes below. If any of them match, the product is part of this recall.
Lot numbers (2)
- 0353 - 0355
- 0357 - 0363
Distribution
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