Helena Laboratories Recalls SPIFE Alkaline Hemoglobin Kits Due to Incorrect Instructions
Helena Laboratories is recalling 899 SPIFE Alkaline Hemoglobin Kits because they contain incorrect instruction inserts referencing unavailable electrode parameters.
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 recall is classified as FDA Class III, which by definition is unlikely to cause adverse health consequences. The issue is a documentation error involving incorrect instruction inserts rather than a direct physical hazard.
Plain-English summary
Helena Laboratories, Corp. is recalling 899 units of the SPIFE Alkaline Hemoglobin Kit, Catalog No. 3415. This product is used for the separation and quantitation of hemoglobins by agarose electrophoresis using the SPIFE systems. The recall involves specific lots manufactured in 2017 and 2018, with expiration dates ranging from September 30, 2018, to December 31, 2018.
The recall was initiated because the gel kits contained a newer revision of the Customer Procedures instructions than intended. The incorrect inserts refer to updated parameters associated with new electrodes that have not yet been made available to users. This discrepancy could lead to improper use of the kit if users follow the instructions for equipment they do not possess.
The affected products were distributed in the United States to the following states: Ohio, New York, Michigan, Indiana, Illinois, Mississippi, Texas, Connecticut, New Jersey, Kentucky, Florida, Maryland, Georgia, Pennsylvania, Arizona, Missouri, Virginia, South Carolina, Louisiana, Kansas, Washington, and Wisconsin. The products were also distributed internationally to Colombia, Brazil, and Taiwan. Users should stop using the affected kits and contact the manufacturer for instructions on return or replacement.
The recalled product
- Product
- SPIFE Alkaline Hemoglobin Kit, Cat. No. 3415, for use in the separation and quantitation of hemoglobins by agarose electrophoresis using the SPIFE systems
- Manufacturer
- Helena Laboratories, Corp.
- Hazard
- Affected units
- 899
Distribution
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