Helena Laboratories, Inc. recalls

5 recalls on record · latest: April 4, 2017

Official U.S. recall history for Helena Laboratories, Inc., compiled from official government records.

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Free and Total Protein S ELISA Kit Cat recalled over labeling errors

April 4, 2017 · Medical device recalls Moderate risk Internal components of the Protein S ELISA Antigen Kit (Lot: 3-16-5292) were mi…

Helena Laboratories, Inc. recalls Cascade Abrazo c-ACT-LR Test Card IVD FOR IN VITRO DIAGNOSTIC USE Store at 2 to 8 C HELENA LABORATORIES 003366 12/13(2)…

February 24, 2017 · Medical device recalls Moderate risk Due to some cards in this lot reported to have experienced variations in result…

Helena Laboratories, Inc. recalls Gel Alkaline Phosphatase Isoenzyme Control Kit: Gel Alkaline Phosphatase Isoenzyme Control Cat. No. 5104 1 x 2.0 mL FOR…

November 7, 2016 · Medical device recalls Due to a customer experiencing complaints on bone fraction of assay not being i…

Helena Laboratories, Inc. recalls Titan Gel Serum Protein Control: SPE Control Cat. No 5136 1 x 2.0 mL

October 14, 2016 · Medical device recalls Moderate risk Due to customer-experienced complaints on narrow assay range compared to prior…

Helena Laboratories, Inc. recalls Cascade Abrazo c-ACT-LR Test Card IVD FOR IN VITRO DIAGNOSTIC USE Store at 2 to 8 C HELENA LABORATORIES 003366 12/13(2)…

April 20, 2016 · Medical device recalls Moderate risk Due to some cards in this lot experiencing variations in wave form, resulting i…