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Helena Laboratories Recalls
16 recalls on record · October 24, 2018 to June 28, 2023 · Medical Devices
Recalls by year
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Count of recall notices naming this brand, by the year the recall was announced. A quiet year is not proof of a safe year.
June 28, 2023Medical DevicesFDA
Helena Laboratories, Corp. recalls Serrated Blade Applicator Kit (12 Sample), REF: 552687, For use with the Spife Nexus system, Contents: 30 Blade Applicat
Hazard: 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.
June 15, 2022Medical DevicesFDA
Helena Laboratories, Corp. recalls V8 Immunodisplacement Kit REF 1803
Hazard: Due to microbial growth causing interference with interpretation.
February 17, 2021Medical DevicesFDA
Helena Laboratories, Corp. recalls Cascade Abrazo aPTT Test Card - Product Usage: are to be used with the Cascade Abrazo analyzer and are intended for the
Hazard: Intermittent potential for shorter than expected clot times.
December 23, 2020Medical DevicesFDA
Helena Laboratories, Corp. recalls K-ACT Actalyke Clotting Test Tubes that are used in the: ACTALYKE XL ACTIVATED CLOTTING TIME ANALYZER, and ACTALYKE MINI
Hazard: Due to complaints received associated with cracked/split test tube caps.
December 4, 2019Medical DevicesFDA
Helena Laboratories, Corp. recalls Collagen Reagent, Cat. No. 5368, 2 X 1 mL, For use in platelet aggregation studies, Contains: Collagen (equine tendon) F
Hazard: 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.
December 4, 2019Medical DevicesFDA
Helena Laboratories, Corp. recalls Platelet Aggregation Kit, Cat. No.5369, For use in platelet aggregation studies, Contains: 2X1 mL ADP Reagent containing
Hazard: 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.
November 13, 2019Medical DevicesFDA
Helena Laboratories, Corp. recalls SPIFE Alkaline Hemoglobin Kit, Cat. No. 3415, for use in the separation and quantitation of hemoglobins by agarose e
Hazard: 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.
October 16, 2019Medical DevicesFDA
Helena Laboratories, Corp. recalls SPIFE ImmunoFix-6 Kit, Cat. No. 3401, 3401T, For In-Vitro Diagnostic Use. The firm name on the label is Helena Laborato
Hazard: The plates do not have wells punched for the controls in the patient 1 area.
October 9, 2019Medical DevicesFDA
Helena Laboratories, Corp. recalls Cascade Abrazo aPTT Test Card, Model 5722, For Export Only. The firm name on the label is Helena Laboratories, Beaumont
Hazard: Some of the cards show occasional shorter clot times than the expected variation resulting in a potential false negative result on the screening assay.
September 11, 2019Medical DevicesFDA
Helena Laboratories, Inc. recalls Titan Gel Serum Protein Control: SPE Control Cat. No 5136 1 x 2.0 mL
Hazard: Due to customer-experienced complaints on narrow assay range compared to prior lots and the user being out of assay range.
July 17, 2019Medical DevicesFDA
Helena Laboratories, Corp. recalls ColoCARE, Cat. No. 5651, packaged 50 envelopes/box, For In-Vitro Diagnostic Use. The firm name on the label is Helena L
Hazard: The positive control on some tests of the lots did not appropriately react within the specified timeframe to verify the test was functioning correctly.
July 17, 2019Medical DevicesFDA
Helena Laboratories, Corp. recalls ColoCARE, Cat. No. 5650, packaged 250 envelopes/box, For In-Vitro Diagnostic Use. The firm name on the label is Helena
Hazard: The positive control on some tests of the lots did not appropriately react within the specified timeframe to verify the test was functioning correctly.
December 19, 2018Medical DevicesFDA
Helena Laboratories, Inc. recalls Cascade Abrazo c-ACT-LR Test Card IVD FOR IN VITRO DIAGNOSTIC USE Store at 2 to 8 C HELENA LABORATORIES 003366 12/1
Hazard: Due to some cards in this lot experiencing variations in wave form, resulting in some cards with shorter or longer times than expected
December 12, 2018Medical DevicesFDA
Helena Laboratories, Inc. recalls Cascade Abrazo c-ACT-LR Test Card IVD FOR IN VITRO DIAGNOSTIC USE Store at 2 to 8 C HELENA LABORATORIES 003366 12/1
Hazard: 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.
December 12, 2018Medical DevicesFDA
Helena Laboratories, Inc. recalls Gel Alkaline Phosphatase Isoenzyme Control Kit: Gel Alkaline Phosphatase Isoenzyme Control Cat. No. 5104 1 x 2.0 mL F
Hazard: Due to a customer experiencing complaints on bone fraction of assay not being in range. The complaint: ~12% lower enzyme activity was noted.
October 24, 2018Medical DevicesFDA
Helena Laboratories, Inc. recalls "Free and Total Protein S ELISA Kit" Cat. No. 5292 For use in the quantitation of free and total Protein antigen in citr
Hazard: 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.