Helena Laboratories, Corp.
Complete recall history across all FDA and CPSC categories — 11 total recalls
Helena Laboratories, Corp. appears in recall records across 1 category. This page consolidates all FDA food, drug, and medical device enforcement actions, plus CPSC consumer product recalls associated with this company. Recall data is sourced from openFDA and CPSC public databases.
Device Recalls (11)
FDA medical device enforcement actions by Helena Laboratories, Corp.
| Date | Product | Reason | Class |
|---|---|---|---|
| May 2, 2023 | Serrated Blade Applicator Kit (12 Sample), REF: 552687, For use with the Spif... | Packaging for a serrated blade applicator kit (12 Sample) may contain a serra... | Class II |
| Apr 6, 2022 | V8 Immunodisplacement Kit REF 1803 | Due to microbial growth causing interference with interpretation. | Class II |
| Jan 5, 2021 | Cascade Abrazo aPTT Test Card - Product Usage: are to be used with the Cascad... | Intermittent potential for shorter than expected clot times. | Class II |
| Nov 9, 2020 | K-ACT Actalyke Clotting Test Tubes that are used in the: ACTALYKE XL ACTIVATE... | Due to complaints received associated with cracked/split test tube caps. | Class II |
| Aug 8, 2018 | ColoCARE, Cat. No. 5650, packaged 250 envelopes/box, For In-Vitro Diagnostic ... | The positive control on some tests of the lots did not appropriately react wi... | Class II |
| Aug 8, 2018 | ColoCARE, Cat. No. 5651, packaged 50 envelopes/box, For In-Vitro Diagnostic U... | The positive control on some tests of the lots did not appropriately react wi... | Class II |
| May 23, 2018 | Collagen Reagent, Cat. No. 5368, 2 X 1 mL, For use in platelet aggregation st... | Through an investigation, it has been determined that vials of Collagen packa... | Class III |
| May 23, 2018 | Platelet Aggregation Kit, Cat. No.5369, For use in platelet aggregation studi... | Through an investigation, it has been determined that vials of Collagen packa... | Class III |
| Feb 27, 2018 | SPIFE Alkaline Hemoglobin Kit, Cat. No. 3415, for use in the separation a... | Lots of gel kits contained a newer revision of the Customer Procedures instru... | Class III |
| Dec 7, 2017 | Cascade Abrazo aPTT Test Card, Model 5722, For Export Only. The firm name on... | Some of the cards show occasional shorter clot times than the expected variat... | Class II |
| Jul 21, 2017 | SPIFE ImmunoFix-6 Kit, Cat. No. 3401, 3401T, For In-Vitro Diagnostic Use. Th... | The plates do not have wells punched for the controls in the patient 1 area. | Class II |
Frequently Asked Questions
A high number of recalls does not necessarily indicate that a company is unsafe. Large manufacturers that produce thousands of products across multiple categories will statistically appear in recall databases more frequently. What matters more is the severity of each recall (Class I being the most serious), the speed of response, and whether the company proactively identified and addressed the issue. Companies with robust safety programs often catch problems earlier.
Food, drug, and medical device recall data comes from the FDA's openFDA enforcement database, which contains all FDA enforcement reports. Consumer product recall data comes from the U.S. Consumer Product Safety Commission (CPSC). Both sources are public government databases that are updated regularly. RecallCheck aggregates these sources to provide a unified view of a company's recall history.
The FDA classifies recalls into three categories. Class I is the most serious — there is a reasonable probability that use of or exposure to the product will cause serious adverse health consequences or death. Class II means the product may cause temporary or medically reversible health problems, or the probability of serious consequences is remote. Class III is the least serious — the product is unlikely to cause adverse health consequences. CPSC product recalls do not use this classification system.
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