FDAMay 24, 2016device
QuickSlide MGS-80, Automated Mutli-Slide Gram Stainer/GramPRO-80. Systematically stains, rinses, decolorizes, and counter-stains the provided biological sample and slide.
Official recall recorded by the U.S. Food & Drug Administration.
The hazard
Discrepant culture and gram stain results, which could potentially lead to misdiagnosis or improper treatment of a patient.
What to do
FDA enforcement status: Terminated
Brands named
hardy diagnosticshardy
Recall history
Other federal recalls tied to the same brand — a factual pattern, straight from the source data.
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- FDA(1)(2) LeadCare¿ II Blood Lead Test Kit, (3)LeadCare¿ II 5X Blood Lead Test Kit, (4)LeadCare¿ II 9X Blood Lead Test Kit ; Catalog Number(s): (1) 70-6762, (2) 70-6762RUO, (3) 70-8404 (Box containing 5 Test Kits), (4) 70-9000 (Box containing 9 test kits); The LeadCare II kit is provided with the fo...2026-03-13
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