Helena Laboratories Recalls SPIFE ImmunoFix-6 Kits Due to Missing Control Wells
Helena Laboratories is recalling 24 SPIFE ImmunoFix-6 kits because the plates lack control wells in the patient 1 area.
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 2/5 (Moderate).
Minor labeling or packaging issue, or a voluntary precautionary recall. Risk of harm is low but real — follow the manufacturer's instructions.
Our severity reasoning: The recall is classified as FDA Class II, and the defect is a manufacturing error (missing wells) that compromises diagnostic validity without an explicit report of patient injury or death, fitting the criteria for a moderate severity precautionary recall.
Plain-English summary
Helena Laboratories, Corp. is recalling 24 units of the SPIFE ImmunoFix-6 Kit (Cat. No. 3401, 3401T) for in-vitro diagnostic use. The recall is due to a manufacturing defect where the plates do not have wells punched for the controls in the patient 1 area.
The affected product is identified by Lot 35-17-552583 with an expiration date of 4/30/2018. Distribution was made to Indiana, Kentucky, Massachusetts, Ohio, Oregon, Tennessee, and Texas, as well as to government entities and Chile.
Users of this product should stop using the affected kits and contact the recalling firm for instructions on return or replacement.
The recalled product
- Product
- SPIFE ImmunoFix-6 Kit, Cat. No. 3401, 3401T, For In-Vitro Diagnostic Use. The firm name on the label is Helena Laboratories, Beaumont, TX.
- Manufacturer
- Helena Laboratories, Corp.
- Affected units
- 24
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 35-17-552583
- exp. date 4/30/2018
Distribution
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