Beaumont, TX, United States
Helena Laboratories, Corp. recalls
14 recalls recorded since 2018, most recently on 2 May 2023. 6 are listed as ongoing. Status and classification are as published by the FDA.
Recalls14
Ongoing (FDA)6
Terminated or completed8
Class I (FDA)0
Ongoing Class II Medical devices
- Recall started
- 2 May 2023
- Reason
- Packaging for a serrated blade applicator kit (12 Sample) may contain a serrated blade applicator (18 sample). This results in a characteristic pattern of missed or light samples on the gel, leading to incorrect or no result, or delay in result.
- Distribution
- Distribution to US states of PA, NE, MI, FL, AR, NY, TX, and CA, and to Thailand.
- Initiated
- Voluntary: Firm initiated
- Recall number
- Z-1975-2023
- Serrated Blade Applicator Kit (12 Sample), REF: 552687, For use with the Spife Nexus system, Contents: 30 Blade Applicators. used in invitro diagnostics
Ongoing Class II Medical devices
- Recall started
- 6 April 2022
- Reason
- Due to microbial growth causing interference with interpretation.
- Distribution
- U.S.: FL, MO, OH, and TX O.U.S.: Canada, Uruguay, and Vietnam,
- Initiated
- Voluntary: Firm initiated
- Recall number
- Z-1244-2022
- V8 Immunodisplacement Kit REF 1803
Terminated Class II Medical devices
- Recall started
- 5 January 2021
- Terminated
- 19 November 2024
- Reason
- Intermittent potential for shorter than expected clot times.
- Distribution
- Worldwide distribution - U.S. Nationwide distribution and the countries of Germany, Italy, Romania, Australia, Chile.
- Initiated
- Voluntary: Firm initiated
- Recall number
- Z-1108-2021
- Cascade Abrazo aPTT Test Card - Product Usage: are to be used with the Cascade Abrazo analyzer and are intended for the determination of the activated Partial Thromboplastin Time (aPTT) of citrated whole blood or plasma,
Ongoing Class II Medical devices
- Recall started
- 9 November 2020
- Reason
- Due to complaints received associated with cracked/split test tube caps.
- Distribution
- Worldwide distribution - U.S. Nationwide including in the states of NJ, NY, PA and TX. The countries of Austria, Canada, England, France, Italy, Portugal, Russia, Spain.
- Initiated
- Voluntary: Firm initiated
- Recall number
- Z-0635-2021
- K-ACT Actalyke Clotting Test Tubes that are used in the: ACTALYKE XL ACTIVATED CLOTTING TIME ANALYZER, and ACTALYKE MINI ACTIVATED CLOTTING TIME TEST SYSTEM.
Ongoing Class II Medical devices
- Recall started
- 8 August 2018
- Reason
- 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
- 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.
- Initiated
- Voluntary: Firm initiated
- Recall numbers
- Z-1950-2019, Z-1949-2019
- ColoCARE, Cat. No. 5651, packaged 50 envelopes/box, For In-Vitro Diagnostic Use. The firm name on the label is Helena Laboratories, Beaumont, TX.
- ColoCARE, Cat. No. 5650, packaged 250 envelopes/box, For In-Vitro Diagnostic Use. The firm name on the label is Helena Laboratories, Beaumont, TX.
Ongoing Class III Medical devices
- Recall started
- 23 May 2018
- Reason
- Through an investigation, it has been determined that vials of Collagen packaged within the Collagen Reagent and Platelet Aggregation Kit may contain particulate matter or microbial growth.
- Distribution
- US:TX, WV, OH, TN, GA, TN, NY, ME, MA,LA, AZ OUS: Israel, Korea, Australia, Indonesia, Canada, Thailand, Colombia, Brasil , China , Taiwan
- Initiated
- Voluntary: Firm initiated
- Recall numbers
- Z-0536-2020, Z-0537-2020
- Platelet Aggregation Kit, Cat. No.5369, For use in platelet aggregation studies, Contains: 2X1 mL ADP Reagent containing adenosine diphosphate, 2X 1 mL Collagen Reagent containing collagen (equine tendon), 2 x 1 mL Epine
- Collagen Reagent, Cat. No. 5368, 2 X 1 mL, For use in platelet aggregation studies, Contains: Collagen (equine tendon) For In-Vitro Diagnostic Use,
Ongoing Class III Medical devices
- Recall started
- 27 February 2018
- Reason
- Lots of gel kits contained a newer revision of the Customer Procedures instructions than intended. The incorrect inserts refer to updated parameters associated with new electrodes -- which have not yet been made available to users.
- Distribution
- US: OH, NY, MI, IN, IL, MS, TX, CT, NJ, KY, FL, MD, GA, PA, AZ, MO, VA, SC, LA, KS, WA, WI, OUS: Colombia, Brasil, Taiwan
- Initiated
- Voluntary: Firm initiated
- Recall number
- Z-0297-2020
- SPIFE Alkaline Hemoglobin Kit, Cat. No. 3415, for use in the separation and quantitation of hemoglobins by agarose electrophoresis using the SPIFE systems
Terminated Class II Medical devices
- Recall started
- 7 December 2017
- Terminated
- 9 June 2020
- Reason
- Some of the cards show occasional shorter clot times than the expected variation resulting in a potential false negative result on the screening assay.
- Distribution
- Distribution was made to Germany and Australia. There was no U.S. distribution.
- Initiated
- Voluntary: Firm initiated
- Recall number
- Z-2761-2019
- Cascade Abrazo aPTT Test Card, Model 5722, For Export Only. The firm name on the label is Helena Laboratories, Beaumont, TX.
Terminated Class II Medical devices
- Recall started
- 21 July 2017
- Terminated
- 19 June 2020
- Reason
- The plates do not have wells punched for the controls in the patient 1 area.
- Distribution
- Distribution was made to IN, KY, MA, OH, OR, TN, and TX. There was government distribution. Foreign distribution was made to Chile.
- Initiated
- Voluntary: Firm initiated
- Recall number
- Z-0045-2020
- SPIFE ImmunoFix-6 Kit, Cat. No. 3401, 3401T, For In-Vitro Diagnostic Use. The firm name on the label is Helena Laboratories, Beaumont, TX.
Terminated Class II Medical devices
- Recall started
- 4 April 2017
- Terminated
- 14 May 2020
- Reason
- Internal components of the Protein S ELISA Antigen Kit (Lot: 3-16-5292) were mislabeled. The Protein S Conjugate Solution is labeled as Substrate, and the Substrate is labeled as Protein S conjugate.
- Distribution
- International distribution to country of: Jordan
- Initiated
- Voluntary: Firm initiated
- Recall number
- Z-0106-2019
- "Free and Total Protein S ELISA Kit" Cat. No. 5292 For use in the quantitation of free and total Protein antigen in citrated human plasma Contains: 96 Protein S: Ag Microwells, 3 x 0.5mL ELISA Reference Plasma, 1x12 m
Terminated Class II Medical devices
- Recall started
- 24 February 2017
- Terminated
- 20 October 2023
- Reason
- 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
- US: Products under control of Manufacturer in TX OUS: Four International Distributors - Australia, Netherlands, Italy, and England
- Initiated
- Voluntary: Firm initiated
- Recall number
- Z-0561-2019
- 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
Terminated Class III Medical devices
- Recall started
- 7 November 2016
- Terminated
- 15 January 2021
- Reason
- Due to a customer experiencing complaints on bone fraction of assay not being in range. The complaint: ~12% lower enzyme activity was noted.
- Distribution
- Worldwide Distribution: US (nationwide) to states of: GA, IN, and MI, and countries of: Australia, Brazil, Canada, Japan and Hong Kong.
- Initiated
- Voluntary: Firm initiated
- Recall number
- Z-0529-2019
- Gel Alkaline Phosphatase Isoenzyme Control Kit: Gel Alkaline Phosphatase Isoenzyme Control Cat. No. 5104 1 x 2.0 mL FOR IN-VITRO DIAGNOSTIC USE Gel Alkaline Phosphatase Isoenzyme Control 20mL 001831 Alkaline
Terminated Class II Medical devices
- Recall started
- 14 October 2016
- Terminated
- 12 October 2023
- Reason
- Due to customer-experienced complaints on narrow assay range compared to prior lots and the user being out of assay range.
- Distribution
- Domestic: FL, IL, MN, MT, NY, OH, TN, TX, VA, and WI OUS: Australia, Canada, Jordan, and South Korea
- Initiated
- Voluntary: Firm initiated
- Recall number
- Z-2434-2019
- Titan Gel Serum Protein Control: SPE Control Cat. No 5136 1 x 2.0 mL
Terminated Class II Medical devices
- Recall started
- 20 April 2016
- Terminated
- 15 February 2024
- Reason
- Due to some cards in this lot experiencing variations in wave form, resulting in some cards with shorter or longer times than expected
- Distribution
- US Distribution to state of TX and internationally to: Australia, Netherlands, Italy, and England.
- Initiated
- Voluntary: Firm initiated
- Recall number
- Z-0594-2019
- 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 The Cascade Abrazo c-ACT-LR test cards are activated clotting time tests
A terminated FDA recall means the FDA has determined that all reasonable efforts to remove or correct the product have been made. What statuses mean.