Home / Recalls / Helena Laboratories, Corp. / Z-1949-2019

Z-1949-2019 Class II Ongoing

Recalled by Helena Laboratories, Corp. — Beaumont, TX

Recall Details

Product Type
Devices
Report Date
July 17, 2019
Initiation Date
August 8, 2018
Termination Date
N/A
Voluntary/Mandated
Voluntary: Firm initiated
Product Quantity
27/250 pouch kits

Product Description

ColoCARE, Cat. No. 5650, packaged 250 envelopes/box, For In-Vitro Diagnostic Use. The firm name on the label is Helena Laboratories, Beaumont, TX.

Reason for Recall

The positive control on some tests of the lots did not appropriately react within the specified timeframe to verify the test was functioning correctly.

Distribution Pattern

Distribution was made to AK, AR, AZ, CA, CO, CT, FL, GA, IA, ID, IL, IN, KY, LA, MA, MD, MI, MO, MS, MT, NC, ND, NE, NV, NY, OH, OK, PA, SD, TN, TX, VA, WA, and WY. There was no foreign/military/government distribution.

Code Information

Kit lots 1-17-5650, exp. 8/31/2018, and 2-17-5650, exp. 9/30/2018. These kit lots contain ColoCARE pad lot numbers 1-17-551039, exp. 8/31/2018, and 2-17-551039, exp. 9/30/2018.

Other recalls by Helena Laboratories, Corp.

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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)
  • Z-0635-2021 Class II — K-ACT Actalyke Clotting Test Tubes that are used in the: ACTALYKE XL ACTIVATED C (November 9, 2020)
  • 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)
  • Z-0045-2020 Class II — SPIFE ImmunoFix-6 Kit, Cat. No. 3401, 3401T, For In-Vitro Diagnostic Use. The f (July 21, 2017)