Home / Recalls / Helena Laboratories, Corp. / Z-0045-2020

Z-0045-2020 Class II Terminated

Recalled by Helena Laboratories, Corp. — Beaumont, TX

Recall Details

Product Type
Devices
Report Date
October 16, 2019
Initiation Date
July 21, 2017
Termination Date
June 19, 2020
Voluntary/Mandated
Voluntary: Firm initiated
Product Quantity
24 kits

Product Description

SPIFE ImmunoFix-6 Kit, Cat. No. 3401, 3401T, For In-Vitro Diagnostic Use. The firm name on the label is Helena Laboratories, Beaumont, TX.

Reason for Recall

The plates do not have wells punched for the controls in the patient 1 area.

Distribution Pattern

Distribution was made to IN, KY, MA, OH, OR, TN, and TX. There was government distribution. Foreign distribution was made to Chile.

Code Information

Lot 35-17-552583, exp. date 4/30/2018

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  • Z-1108-2021 Class II — Cascade Abrazo aPTT Test Card - Product Usage: are to be used with the Cascade A (January 5, 2021)
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  • Z-1949-2019 Class II — ColoCARE, Cat. No. 5650, packaged 250 envelopes/box, For In-Vitro Diagnostic Use (August 8, 2018)
  • Z-1950-2019 Class II — ColoCARE, Cat. No. 5651, packaged 50 envelopes/box, For In-Vitro Diagnostic Use. (August 8, 2018)
  • Z-0536-2020 Class III — Platelet Aggregation Kit, Cat. No.5369, For use in platelet aggregation studies, (May 23, 2018)
  • Z-0537-2020 Class III — Collagen Reagent, Cat. No. 5368, 2 X 1 mL, For use in platelet aggregation studi (May 23, 2018)
  • Z-0297-2020 Class III — SPIFE Alkaline Hemoglobin Kit, Cat. No. 3415, for use in the separation and (February 27, 2018)
  • Z-2761-2019 Class II — Cascade Abrazo aPTT Test Card, Model 5722, For Export Only. The firm name on th (December 7, 2017)