Overview of recall records associated with Helena Laboratories, Inc., including dates, categories and classifications where available.
Classification mix: Class II: 3, Class III: 1.
Due to customer-experienced complaints on narrow assay range compared to prior lots and the user being out of assay range.
Due to some cards in this lot experiencing variations in wave form, resulting in some cards with shorter or longer times than expected
Due to a customer experiencing complaints on bone fraction of assay not being in range. The complaint: ~12% lower enzyme activity was noted.
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.
This page summarizes recall records in which the official source identifies Helena Laboratories, Inc. as the recalling firm or manufacturer. The number of records should not be treated as a safety rating or a measure of company size, because recall counts depend on product mix, reporting periods and how government records are organized.
Compare the dates, categories and classifications together rather than relying on the total alone. Open an individual record for the recalled product, reason, distribution details and current instructions available from the source.
