Helena Laboratories Recalls Titan Gel Serum Protein Control Kits
Helena Laboratories is recalling 65 kits of Titan Gel Serum Protein Control due to customer complaints about a narrow assay range.
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, but the source text does not report any injuries, illnesses, or hospitalizations. The hazard is limited to performance issues (narrow assay range) without reported harm, fitting the criteria for a moderate severity score.
Plain-English summary
Helena Laboratories, Inc. is recalling 65 kits of Titan Gel Serum Protein Control (Catalog No. 5136). The recall is being conducted due to customer-experienced complaints regarding a narrow assay range compared to prior lots, which resulted in users being out of the assay range.
The affected product is identified by Lot Code 1-16-5136 and has an expiration date of 3-17. The product was distributed domestically in Florida, Illinois, Minnesota, Montana, New York, Ohio, Tennessee, Texas, Virginia, and Wisconsin, as well as internationally in Australia, Canada, Jordan, and South Korea.
Users should stop using the affected product and contact Helena Laboratories for further instructions.
The recalled product
- Product
- Titan Gel Serum Protein Control: SPE Control Cat. No 5136 1 x 2.0 mL
- Manufacturer
- Helena Laboratories, Inc.
- Hazard
- Affected units
- 65
Distribution
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