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FDAOctober 14, 2016device

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

Official recall recorded by the U.S. Food & Drug Administration.

The hazard

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

What to do

FDA enforcement status: Terminated

Brands named

helena laboratorieshelena

Recall history

Other federal recalls tied to the same brand — a factual pattern, straight from the source data.

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