Brand recall history

Helena Laboratories recalls

Every FDA recall record we found for Helena Laboratories, newest first. Updated Oct. 11, 2026.

14 recalls since 2018. The most recent was on June 28, 2023.

Last 12 months: 0
Most recent: 2023-06
Most serious (FDA Class I): 0
Last 30 days: 0

Recalls by year

2018–2026

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Class I (FDA, most serious)Other recalls

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All recalls

June 28, 2023Serrated Blade Applicator Kit (12 Sample)… Class IIPackaging for a serrated blade applicator kit (12 Sample) may contain a serrated blade applicator (18 sample). This results in a characteristic…
June 15, 2022V8 Immunodisplacement Kit REF 1803 Class IIDue to microbial growth causing interference with interpretation.
Feb. 17, 2021Cascade Abrazo aPTT Test Card… Class IIIntermittent potential for shorter than expected clot times.
Dec. 23, 2020K-ACT Actalyke Clotting Test Tubes that are used in the: ACTALYKE XL ACTIVATED CLOTTING TIME ANALYZER… Class IIDue to complaints received associated with cracked/split test tube caps.
Dec. 4, 2019Platelet Aggregation Kit… and 1 more product Class IIIThrough an investigation, it has been determined that vials of Collagen packaged within the Collagen Reagent and Platelet Aggregation Kit may contain…
Nov. 13, 2019SPIFE Alkaline Hemoglobin Kit… Class IIILots of gel kits contained a newer revision of the Customer Procedures instructions than intended. The incorrect inserts refer to updated parameters…
Oct. 16, 2019SPIFE ImmunoFix-6 Kit… Class IIThe plates do not have wells punched for the controls in the patient 1 area.
Oct. 9, 2019Cascade Abrazo aPTT Test Card… Class IISome of the cards show occasional shorter clot times than the expected variation resulting in a potential false negative result on the screening…
Sept. 11, 2019Titan Gel Serum Protein Control: SPE Control Cat… Class IIDue to customer-experienced complaints on narrow assay range compared to prior lots and the user being out of assay range.
July 17, 2019ColoCARE… and 1 more product Class IIThe positive control on some tests of the lots did not appropriately react within the specified timeframe to verify the test was functioning…
Dec. 19, 2018Cascade Abrazo c-ACT-LR Test Card IVD FOR IN VITRO DIAGNOSTIC USE Store at 2 to 8 C HELENA LABORATORIES… Class IIDue to some cards in this lot experiencing variations in wave form, resulting in some cards with shorter or longer times than expected
Dec. 12, 2018Cascade Abrazo c-ACT-LR Test Card IVD FOR IN VITRO DIAGNOSTIC USE Store at 2 to 8 C HELENA LABORATORIES… Class IIDue to some cards in this lot reported to have experienced variations in results, (verified by wave form), resulting in some cards with shorter or…
Dec. 12, 2018Gel Alkaline Phosphatase Isoenzyme Control Kit: Gel Alkaline Phosphatase Isoenzyme Control Cat… Class IIIDue to a customer experiencing complaints on bone fraction of assay not being in range. The complaint: ~12% lower enzyme activity was noted.
Oct. 24, 2018"Free and Total Protein S ELISA Kit" Cat… Class IIInternal components of the Protein S ELISA Antigen Kit (Lot: 3-16-5292) were mislabeled. The Protein S Conjugate Solution is labeled as Substrate…

How we match: a recall is listed here when the agency names Helena Laboratories as the company that filed it. Sources: FDA enforcement reports and FDA-posted company announcements, CPSC recall notices and NHTSA recall campaigns.

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