Hardy Diagnostics Recalls QuickSlide MGS-80 Gram Stainers Due to Discrepant Results
Hardy Diagnostics is recalling 25 QuickSlide MGS-80 and GramPRO-80 automated Gram stainers because they may produce discrepant culture and Gram stain results, potentially leading to misdiagnosis or improper patient treatment.
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 4/5 (Severe).
The hazard poses a serious risk of illness, injury, or structural failure. Stop using the product immediately and contact the manufacturer for a refund or repair.
Our severity reasoning: The recall is classified as FDA Class II and involves a risk of misdiagnosis or improper treatment of patients, which aligns with the rubric criteria for a Severe (4) rating involving significant injury or risk of harm.
Plain-English summary
Hardy Diagnostics is recalling 25 units of the QuickSlide MGS-80 and GramPRO-80 automated multi-slide Gram stainers. These devices are used to systematically stain, rinse, decolorize, and counter-stain biological samples and slides. The recall affects all units manufactured between October 2014 and May 2016.
The recall was initiated because the devices may produce discrepant culture and Gram stain results. These discrepancies could potentially lead to the misdiagnosis of a patient or the administration of improper treatment. The FDA has classified this as a Class II recall.
The affected units were distributed in the United States to the following states: California, Texas, Nebraska, Oklahoma, Louisiana, North Carolina, Pennsylvania, Arizona, New York, Virginia, New Mexico, Michigan, and West Virginia. Users of these devices should contact Hardy Diagnostics for further instructions on how to proceed.
The recalled product
- Product
- QuickSlide MGS-80, Automated Mutli-Slide Gram Stainer/GramPRO-80. Systematically stains, rinses, decolorizes, and counter-stains the provided biological sample and slide.
- Manufacturer
- Hardy Diagnostics
- Affected units
- 25
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)
- All units manufactured between October 2014 and May 2016.
Distribution
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