Health product recall

Access TSH (3RD IS) (Calibrators) (2020-05-13)

Starting date:
May 13, 2020
Posting date:
June 5, 2020
Type of communication:
Medical Device Recall
Subcategory:
Medical Device
Hazard classification:
Type II
Source of recall:
Health Canada
Issue:
Medical Devices
Audience:
General Public, Healthcare Professionals, Hospitals
Identification number:
RA-73243

Last updated: 2020-06-05

Affected Products

Access TSH (3RD IS) (Calibrators)

Reason

Beckman Coulter has determined through an internal investigation that the Access TSH (3rd IS) Calibrators (Lot Number 921647) was manufactured with inadequate concentrations of preservative and Bovine Serum Albumin.

Affected products

Access TSH (3RD IS) (Calibrators)

Lot or serial number

921647

Model or catalog number

B63285

Companies
Manufacturer
Beckman Coulter Inc.
250 S. Kraemer Blvd.
Brea
92821
California
UNITED STATES