Health product recall

Body Fluid Controls (2020-05-18)

Starting date:
May 18, 2020
Posting date:
June 5, 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-73253



Last updated: 2020-06-05

Affected Products

Body Fluid Controls

Reason

Beckman Coulter has identified through customer complaints that lots of Body Fluid Controls level 1 have been failing below the expected range of red blood cells (RBC).

Affected products

Body Fluid Controls

Lot or serial number
  • 4512960K
  • 4512970K
  • 4512980K
  • 4512990K
  • 4513000K
  • 4513010K
Model or catalog number
  • 628030
Companies
Manufacturer

Beckman Coulter Inc.

250 S. Kraemer Blvd.

Brea

92821

California

UNITED STATES