Helena Laboratories recalls
Helena Laboratories appears in 16 official U.S. recall notices indexed by RecallRadar, most recently on 2023-06-28.
Company names are normalized from agency data (legal suffixes removed), so related firms may appear under separate pages.
Recall summary
| Recall notices | 16 |
|---|---|
| Published | 2018-10-24 to 2023-06-28 |
| By agency | FDA Device (16) |
| By classification | Class II (12), Class III (4) |
| By status | ongoing (8), terminated (8) |
| Distribution named in notices | AK, AR, AZ, CA, CO, CT, FL, GA, IA, ID, IL, IN, KS, KY, LA, MA, MD, ME, MI, MN, MO, MS, MT, NC, ND, NE, NJ, NV, NY, OH, OK, OR, PA, SC, SD, TN, TX, US, VA, WA, WI, WV, WY |
Recalls
- Serrated Blade Applicator Kit (12 Sample), REF: 552687, For use with the Spife Nexus system, Contents: 30 Blade Applicators. used in invitr…
FDA Device · Class II · 2023-06-28 · Helena Laboratories
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 r… - V8 Immunodisplacement Kit REF 1803
FDA Device · Class II · 2022-06-15 · Helena Laboratories
Reason: Due to microbial growth causing interference with interpretation. - Cascade Abrazo aPTT Test Card - Product Usage: are to be used with the Cascade Abrazo analyzer and are intended for the determination of th…
FDA Device · Class II · 2021-02-17 · Helena Laboratories
Reason: Intermittent potential for shorter than expected clot times. - K-ACT Actalyke Clotting Test Tubes that are used in the: ACTALYKE XL ACTIVATED CLOTTING TIME ANALYZER, and ACTALYKE MINI ACTIVATED CLOTTING…
FDA Device · Class II · 2020-12-23 · Helena Laboratories
Reason: Due to complaints received associated with cracked/split test tube caps. - Collagen Reagent, Cat
FDA Device · Class III · 2019-12-04 · Helena Laboratories
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. - Platelet Aggregation Kit, Cat
FDA Device · Class III · 2019-12-04 · Helena Laboratories
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. - SPIFE Alkaline Hemoglobin Kit, Cat
FDA Device · Class III · 2019-11-13 · Helena Laboratories
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 availab… - SPIFE ImmunoFix-6 Kit, Cat
FDA Device · Class II · 2019-10-16 · Helena Laboratories
Reason: The plates do not have wells punched for the controls in the patient 1 area. - Cascade Abrazo aPTT Test Card, Model 5722, For Export Only
FDA Device · Class II · 2019-10-09 · Helena Laboratories
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. - Titan Gel Serum Protein Control: SPE Control Cat
FDA Device · Class II · 2019-09-11 · Helena Laboratories
Reason: Due to customer-experienced complaints on narrow assay range compared to prior lots and the user being out of assay range. - ColoCARE, Cat
FDA Device · Class II · 2019-07-17 · Helena Laboratories
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. - ColoCARE, Cat
FDA Device · Class II · 2019-07-17 · Helena Laboratories
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. - 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…
FDA Device · Class II · 2018-12-19 · Helena Laboratories
Reason: Due to some cards in this lot experiencing variations in wave form, resulting in some cards with shorter or longer times than expected - Gel Alkaline Phosphatase Isoenzyme Control Kit: Gel Alkaline Phosphatase Isoenzyme Control Cat
FDA Device · Class III · 2018-12-12 · Helena Laboratories
Reason: Due to a customer experiencing complaints on bone fraction of assay not being in range. The complaint: ~12% lower enzyme activity was noted. - 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
FDA Device · Class II · 2018-12-12 · Helena Laboratories
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. - "Free and Total Protein S ELISA Kit" Cat
FDA Device · Class II · 2018-10-24 · Helena Laboratories
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.