Randox Laboratories Ltd.: Medical Device Recall in 2016 - (Recall #: Z-0050-2017)

Updated on March 25, 2026.

See the recall detail below. You can also see other recalls from the same firm in 2016.

Data Source: FDA.

Product Description:

IgE Calibrator Series

Product Classification:

Class II

Date Initiated: September 7, 2016

Date Posted: October 12, 2016

Recall Number: Z-0050-2017

Event ID: 75208

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.

Status: Terminated

Product Quantity: 4

Code Information:

Catalogue number IE2492 Batch number 354213, 386994

Distribution Pattern:

All consignees are in the US.

Voluntary or Mandated:

Voluntary: Firm initiated