Helena Laboratories Recalls Gel Alkaline Phosphatase Isoenzyme Control Kits
Helena Laboratories is recalling 43 Gel Alkaline Phosphatase Isoenzyme Control Kits due to customer complaints of lower enzyme activity.
The agency’s classification
FDA (Devices): Class III
Class III is a situation in which use of or exposure to a violative product is not likely to cause adverse health consequences.
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 1/5 (Low).
Cosmetic or documentation issue. No expected health impact, but the manufacturer is correcting the affected products.
Our severity reasoning: The FDA classified this recall as Class III, which by definition indicates that use of or exposure to the product is not likely to cause adverse health consequences.
Plain-English summary
Helena Laboratories, Inc. is recalling 43 units of the Gel Alkaline Phosphatase Isoenzyme Control Kit (Catalog No. 5104). The recall was initiated after a customer reported that the bone fraction of the assay was not within the expected range, specifically noting approximately 12% lower enzyme activity.
The affected product is an in-vitro diagnostic control used to aid in the identification of alkaline phosphatase isoenzymes by electrophoresis. The recall covers 43 kits, with 6 distributed domestically in the United States (Georgia, Indiana, and Michigan) and 37 distributed internationally to Australia, Brazil, Canada, Japan, and Hong Kong. The specific lot code involved is 1-16-5104.
This recall is classified as Class III by the FDA, indicating that use of or exposure to the product is not likely to cause adverse health consequences. Users of the product should contact Helena Laboratories for further instructions regarding the return or replacement of the affected kits.
The recalled product
- Product
- Gel Alkaline Phosphatase Isoenzyme Control Kit: Gel Alkaline Phosphatase Isoenzyme Control Cat. No. 5104 1 x 2.0 mL FOR IN-VITRO DIAGNOSTIC USE Gel Alkaline Phosphatase Isoenzyme Control 20mL 001831 Alkaline Phosphatase Isoenzyme Control is to be used as a…
- Manufacturer
- Helena Laboratories, Inc.
- Hazard
Distribution
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