Diagnostic reagent kits recalled for incorrect chemical composition
Gibson Bioscience is recalling Potassium Hydroxide 10% diagnostic reagent kits (Lot 21137116, 11 units) manufactured with Hydrogen Peroxide 3% instead of the intended chemical. The wrong solution could cause inaccurate laboratory test results.
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: FDA Class II recall involving substitution of a critical component in a diagnostic device. While no illnesses or injuries have been reported, the wrong chemical composition creates a substantial risk of diagnostic error in clinical laboratory settings.
Plain-English summary
Gibson Bioscience is recalling Potassium Hydroxide 10% (KOH 10%) diagnostic reagent kits due to a critical manufacturing error. A lot of the product (Lot 21137116, UDI 10634853000633) was manufactured with Hydrogen Peroxide 3% instead of the intended Potassium Hydroxide 10% solution.
The affected product is Cat. No. 300145 and consists of 11 kits distributed domestically to medical laboratories and clinical facilities in New York, Kentucky, Maine, North Carolina, Colorado, California, and South Carolina.
Potassium Hydroxide 10% is intended for use in clinical microscopy to help demonstrate yeast and fungal elements in wet specimen preparations by digesting proteinaceous material while preserving the fungal cell wall for microscopic observation. If the incorrect Hydrogen Peroxide solution is used instead, laboratory tests may produce inaccurate or unreliable results.
Laboratories and healthcare facilities that received affected kits should immediately discontinue use of Lot 21137116 and contact Gibson Bioscience for replacement product.
The recalled product
- Product
- Potassium Hydroxide 10% (KOH 10%), Cat. No. 300145 Potassium Hydroxide 10% (KOH 10%) is intended for use in the demonstration of yeast and fungal elements in wet clinical preparations. Potassium Hydroxide digests the proteinaceous material in the specimen, leaving the fungal…
- Manufacturer
- Gibson Bioscience
- Affected units
- 11
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)
- Lot 21137116
- UDI 10634853000633
Distribution
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