Helena Laboratories, Inc. recalls Titan Gel Serum Protein Control: SPE Control Cat. No 5136 1 x 2.0 mL
- Recall date
- October 14, 2016
- Source
- U.S. Food & Drug Administration (FDA) — enforcement report
- Recall number
- Z-2434-2019
- FDA classification
- Class II
- Brand / firm
- Helena Laboratories, Inc.
- Sold / distributed
- Domestic: FL, IL, MN, MT, NY, OH, TN, TX, VA, and WI OUS: Australia, Canada, Jordan, and South Korea
Why it was recalled
Due to customer-experienced complaints on narrow assay range compared to prior lots and the user being out of assay range.
Class II means using this product may cause temporary or medically reversible health problems; the chance of serious harm is remote.
What was recalled
Titan Gel Serum Protein Control: SPE Control Cat. No 5136 1 x 2.0 mL
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