Manufacturer
5 recalls in our database name Helena Laboratories, Inc. as the manufacturing or recalling firm.
Of the 5 recalls from Helena Laboratories, Inc. we have scored against our rubric, 0 (0%) are Critical — deaths or serious injuries reported, or the agency’s own highest classification — and 0 (0%) are Severe.
The manufacturer string comes from the agency’s own source notice — for FDA recalls, the “recalling firm” field; for NHTSA recalls, the vehicle manufacturer; for CPSC recalls, the firm-of-record on the joint press release. A single corporate family can appear under multiple manufacturer strings as agency notices aren’t standardized on a canonical name. If you don’t see recalls you expect, try a parent-company search or a broader full-text search.
Severity scores below are computed from the agency’s classification and the recall text, never from manufacturer behaviour or history. Many manufacturers issue routine corrective actions (software updates, labelling corrections) that are correctly scored low — having recalls on this list isn’t inherently a quality signal.
Helena Laboratories is recalling 65 kits of Titan Gel Serum Protein Control due to customer complaints about a narrow assay range.
Helena Laboratories is recalling Cascade Abrazo c-ACT-LR test cards due to waveform variations that may result in inaccurate clotting time measurements.
Helena Laboratories is recalling 27 kits of Cascade Abrazo c-ACT-LR Test Cards due to reported variations in test results.
Helena Laboratories is recalling 43 Gel Alkaline Phosphatase Isoenzyme Control Kits due to customer complaints of lower enzyme activity.
Helena Laboratories is recalling three Protein S ELISA Antigen Kits because internal components were mislabeled, causing the Substrate and Protein S Conjugate to be swapped.