Health product recall

Assayed Bovine Multi-Sera - Level 1 (2019-06-05)

Starting date:
June 5, 2019
Posting date:
June 21, 2019
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-70261

Last updated: 2019-06-21

Affected Products

Assayed Bovine Multi-Sera - Level 1

Reason

Randox is re-assigning the Mean of all Instruments target and range for Bile Acids (5th Generation Colorimetric) in the Assayed Bovine Multi-Sera Level 1 Control Lot 205SL. Updated value sheets are now available on www.randox.com under Support and Documentation and attached to the email of this contact. No other lots or products are affected by this issue.

Affected products

Assayed Bovine Multi-Sera - Level 1

Lot or serial number

205SL

Model or catalog number

AL1027

Companies
Manufacturer

Randox Laboratories Ltd.

55 Diamond Road

Crumlin, County Antrim

BT29 4QY

UNITED KINGDOM