Health product recall

Access Sensitive Estradiol Calibrators (2020-04-22)

Starting date:
April 22, 2020
Posting date:
May 8, 2020
Type of communication:
Medical Device Recall
Subcategory:
Medical Device
Hazard classification:
Type III
Source of recall:
Health Canada
Issue:
Medical Devices
Audience:
General Public, Healthcare Professionals, Hospitals
Identification number:
RA-73033



Last updated: 2020-05-08

Affected Products

  1. Access Sensitive Estradiol Calibrators

Reason

Beckman Coulter has determined that four current access sensitive estradiol calibrator (P/N B84494) lots share the same lot numbers as four expired access free T3 calibrator (P/N A13430) lots. The access system prevents the configuration of a calibrator lot with duplicate lot numbers, which is already configured on the system.

Affected products

A. Access Sensitive Estradiol Calibrators

Lot or serial number
  • 989909
  • 989910
  • 989911
  • 989912
Model or catalog number
  • B84494
Companies
Manufacturer

Beckman Coulter, Inc.

250 S. Kraemer Blvd.

Brea

92821

California

UNITED STATES