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Helena Laboratories, Inc. recalls Titan Gel Serum Protein Control: SPE Control Cat. No 5136 1 x 2.0 mL
Recalled September 11, 2019 · FDA recall Z-2434-2019 · Helena Laboratories
Hazard
Due to customer-experienced complaints on narrow assay range compared to prior lots and the user being out of assay range. · FDA Class II
Units
65 kits
Sold at
Domestic: FL, IL, MN, MT, NY, OH, TN, TX, VA, and WI OUS: Australia, Canada, Jordan, and South Korea
Description
Due to customer-experienced complaints on narrow assay range compared to prior lots and the user being out of assay range.
Product
Titan Gel Serum Protein Control: SPE Control Cat. No 5136 1 x 2.0 mL
Manufacturer(s)
Helena Laboratories, Inc.
Source: U.S. Food and Drug Administration. Official recall notice on fda.gov →