Home / Recalls / Helena Laboratories, Inc. / Z-0561-2019

Z-0561-2019 Class II Terminated

Recalled by Helena Laboratories, Inc. — Beaumont, TX

FDA device recall Z-0561-2019 was initiated by Helena Laboratories, Inc. on February 24, 2017 and is designated Class II. Reason for recall: Due to some cards in this lot reported to have experienced variations in results, (verified by wave form), resulting in some cards with shorter or longer times than expected. The recall status is terminated (terminated October 20, 2023). Affected quantity: 27 kits.

Recall Details

Product Type
Devices
Report Date
December 12, 2018
Initiation Date
February 24, 2017
Termination Date
October 20, 2023
Voluntary/Mandated
Voluntary: Firm initiated
Product Quantity
27 kits

Product Description

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) FOR EXPORT ONLY

Reason for Recall

Due to some cards in this lot reported to have experienced variations in results, (verified by wave form), resulting in some cards with shorter or longer times than expected.

Distribution Pattern

US: Products under control of Manufacturer in TX OUS: Four International Distributors - Australia, Netherlands, Italy, and England

Code Information

Lot Codes: 1-16-5701 Model/Catalog Number: 5701

Other recalls by Helena Laboratories, Inc.

  • Z-1975-2023 Class II — Serrated Blade Applicator Kit (12 Sample), REF: 552687, For use with the Spife N (May 2, 2023)
  • Z-1244-2022 Class II — V8 Immunodisplacement Kit REF 1803 (April 6, 2022)
  • 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-1949-2019 Class II — ColoCARE, Cat. No. 5650, packaged 250 envelopes/box, For In-Vitro Diagnostic Use (August 8, 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-0536-2020 Class III — Platelet Aggregation Kit, Cat. No.5369, For use in platelet aggregation studies, (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)

FDA data resources