Home / Recalls / Helena Laboratories, Inc. / Z-2434-2019

Z-2434-2019 Class II Terminated

Recalled by Helena Laboratories, Inc. — Beaumont, TX

Recall Details

Product Type
Devices
Report Date
September 11, 2019
Initiation Date
October 14, 2016
Termination Date
October 12, 2023
Voluntary/Mandated
Voluntary: Firm initiated
Product Quantity
65 kits

Product Description

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

Reason for Recall

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

Distribution Pattern

Domestic: FL, IL, MN, MT, NY, OH, TN, TX, VA, and WI OUS: Australia, Canada, Jordan, and South Korea

Code Information

Lot Codes: 1-16-5136 (Scheme: 1(st lot)-(of 20)16-(for C/N )5136) LOT 1-16-5136 EXP 3-17 Model/Catalog Number: 5136 UDI: Primary DI - M52551360

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-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)