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