Recall Z-0529-2019— Helena Laboratories, Inc.

Name: FDA recall Z-0529-2019
Creator: U.S. Food and Drug Administration
Published: 2016-11-07

Class III · Terminated

Class III FDA medical device recall by Helena Laboratories, Inc., initiated 2016-11-07, terminated 2021-01-15. It names one FDA 510(k) clearance: K895528. 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: Due to a customer experiencing complaints on bone fraction of assay not being in range. The complaint: ~12% lower enzyme activity was noted..

Recalling firm: Helena Laboratories, Inc.
Classification: Class III
Status: Terminated
Initiated: 2016-11-07
Terminated: 2021-01-15
Firm location: Beaumont, TX, United States

510(k) clearances named in this recall

1 on FDA's record

K895528 — GEL ALKALINE PHOSPHATASE ISOENZYME CONTROL NO.5104Helena Laboratories·cleared 1989-10-25

K-numbers as listed on FDA's Recall Enterprise System record for this event (openFDA device/recall k_numbers). The recall may also cover devices cleared under other submissions not named here.

Product description

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.

Data sourced from openFDA. This site is unofficial and independent of the FDA.