Microbiologics Recalls KWIK-QC Slides Due to Improper Fixation
Microbiologics Inc is voluntarily recalling KWIK-QC Acid Fast and Mycobacterium slides because control organisms are not properly fixated, posing a contamination risk.
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 involves a risk-of-harm product (medical device) where the hazard is potential contamination, but the source text does not report specific injuries or illnesses, fitting the 'High' severity criteria for risk-of-harm products without reported injury.
Plain-English summary
Microbiologics Inc is initiating a voluntary recall of KWIK-QC Acid Fast Stain Slides (SL42-10) and KWIK-QC Mycobacterium Slides (SL43-10). These products are slide preparations used as quality control challenges to demonstrate the satisfactory performance of staining reagents.
The recall is being conducted because the control organisms on the slides are not properly fixated. This defect may cause users to unintentionally contaminate the patient area of the slide by flooding the control well with stain. The source text notes that this contamination could potentially lead to adverse outcomes, though specific injury or illness counts are not provided.
The affected products include 396 boxes of 10 slides each. The distribution pattern is worldwide, including the United States (specifically CA, IN, MS, NY, OH, PA, and SD) and the countries of Australia, Austria, United Arab Emirates, Malaysia, Taiwan, Japan, Turkey, Belgium, Colombia, Canada, South Africa, and Venezuela. The specific lot numbers involved are SL42-10 Lots 4239 to 4243 and SL43-10 Lots 4333 to 4337. Users should stop using these products and contact the manufacturer for instructions.
The recalled product
- Product
- Microbiologics KWIK-QC SLIDES ( KWIK-QC Acid Fast Stain Slides and KWIK-QC Mycobacterium Slides). Slide preparations serving as quality control challenges to demonstrate satisfactory performance of staining reagents.
- Manufacturer
- Microbiologics Inc
- Hazard
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 (1)
- SL42-10 Lots 4239 to 4243 SL43-10 Lots 4333 to 4337
Distribution
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