Product Wiki · Recalls · U.S. FDA — Device Enforcement

Recall Z-0529-2019 — 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

U.S. FDA — Device Enforcement · United States · 2016-11-07 · Class III

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Agency: U.S. FDA — Device Enforcement
Recall identifier: Z-0529-2019
Date of alert: 2016-11-07
Country / jurisdiction: United States
Risk level: Class III
Risk type: recall
Brand: Helena Laboratories, Inc.
Product category: device
Product type: Devices

Reported risk: Due to a customer experiencing complaints on bone fraction of assay not being in range. The complaint: ~12% lower enzyme activity was noted.

Primary source: https://www.fda.gov/safety/recalls-market-withdrawals-safety-alerts

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ProductGuru indexes recall and safety-alert records from ~30 public agency registries. We are not lawyers, regulators or product-safety consultants. This page restates what the named agency published; consult the primary source above (or qualified counsel in your jurisdiction) before any commercial, medical or safety decision.

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