Gel Alkaline Phosphatase Isoenzyme Control Kit: Gel Alkaline… — Class III medical device recall Z-0529-2019
Terminated recall by Helena Laboratories, Inc., reported 2018-12-12, distributed nationwide. Due to a customer experiencing complaints on bone fraction of assay not being in range. The complaint: ~12% lo
| Recall number | Z-0529-2019 |
|---|---|
| Product type | Medical device |
| Classification | Class III |
| Status | Terminated |
| Voluntary or mandated | Voluntary |
| Recalling firm | Helena Laboratories, Inc., Beaumont, TX, United States |
| Recall initiated | 2016-11-07 |
| Classified | 2018-11-30 |
| Reported by FDA | 2018-12-12 |
| Terminated | 2021-01-15 |
| Distributed | Nationwide (US) |
| Countries outside the US | AU, BR, CA, HK, JP |
| Reason classes | potency |
| Lot numbers | 1-16-5104, 5104 |
| Model numbers | 2.0, 5104 |
Product
Gel Alkaline Phosphatase Isoenzyme Control Kit: Gel Alkaline Phosphatase Isoenzyme Control Cat. No. 5104 1 x 2.0 mL FOR IN-VITRO DIAGNOSTIC USE Gel Alkaline Phosphatase Isoenzyme Control 20mL 001831 Alkaline Phosphatase Isoenzyme Control is to be used as a qualitative and/or quantitative control to aid in the identification of alkaline Phosphatase isoenzymes by electrophoresis.
Reason for recall
Due to a customer experiencing complaints on bone fraction of assay not being in range. The complaint: ~12% lower enzyme activity was noted.
Machine access
This record, with every extracted code, the verbatim FDA record and provenance, is available from the recall API: GET https://api.data.aroqon.com/v1/recalls/Z-0529-2019. Look up any UPC, UDI, NDC or lot with /v1/recalls/lookup?code=…. API docs · free and paid keys.
Source: U.S. Food and Drug Administration enforcement report via openFDA (CC0). Structured by Data Foundry (recall-structuring@2); last changed 2026-09-26. Not affiliated with or endorsed by FDA. Not medical or legal advice.