Recall Z-0050-2017— Randox Laboratories Ltd.

Name: FDA recall Z-0050-2017
Creator: U.S. Food and Drug Administration
Published: 2016-09-07

Class II · Terminated

Class II FDA medical device recall by Randox Laboratories Ltd., initiated 2016-09-07, terminated 2017-09-07. It names one FDA 510(k) clearance: K010855. Product: IgE Calibrator Series. Reason: According to the firm, the IgE Calibrator Series IE2492 (lot 387-392IE) value assignment has now been aligned to the 3rd International Standard for human serum IgE 11/234. Turbidimetric (Non-IFCC Cal.) Quality Control Targets and Ranges now apply. The calibrator value sheet is to be updated with the new values..

Recalling firm: Randox Laboratories Ltd.
Classification: Class II
Status: Terminated
Initiated: 2016-09-07
Terminated: 2017-09-07
Firm location: Crumlin (North), N/A, Ireland

510(k) clearances named in this recall

1 on FDA's record

K010855 — RANDOX IGERandox Laboratories, Ltd.·cleared 2001-05-15

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

IgE Calibrator Series

Reason for recall

According to the firm, the IgE Calibrator Series IE2492 (lot 387-392IE) value assignment has now been aligned to the 3rd International Standard for human serum IgE 11/234. Turbidimetric (Non-IFCC Cal.) Quality Control Targets and Ranges now apply. The calibrator value sheet is to be updated with the new values.

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