medical Class II Updated 2019-09-11

Helena Laboratories, Inc. recalls Titan Gel Serum Protein Control: SPE Control Cat. No 5136 1

Recalled Product

Titan Gel Serum Protein Control: SPE Control Cat. No 5136 1 x 2.0 mL


Hazard / Issue

Due to customer-experienced complaints on narrow assay range compared to prior lots and the user being out of assay range.

Issued by

FDA

Affected States: FL, IL, MN, MT, NY, OH, TN, TX, VA, WI
Lot/Code Info: Lot Codes: 1-16-5136 (Scheme: 1(st lot)-(of 20)16-(for C/N )5136) LOT 1-16-5136 EXP 3-17 Model/Catalog Number: 5136 UDI: Primary DI - M52551360
View official government recall

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