Health product recall

Stem-Kit Reagents (2021-09-27)

Starting date:
September 27, 2021
Posting date:
October 15, 2021
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-76651



Last updated:
2021-10-15

Affected Products

Stem-Kit Reagents

Reason

Beckman Coulter has discovered that the recommended specimen storage temperature and prepared sample stability for some specimen types listed are erroneously indicated in the Stem-Kit reagents instructions for use (PN B60229 REV. AH) and STEMCXP system guide (PN 627260 REV. BC), which may lead to erroneous results.

Affected products

Stem-Kit Reagents

Lot or serial number

(Product within expiry)

  • 200326
  • 200327
  • 200328
  • 200329
  • 200330
  • 200332
Model or catalog number

PN IM3630

Companies
Manufacturer

Immunotech SAS

130 AVENUE DE LATTRE DE TASSIGNY

MARSEILLE CEDEX 09,

13276

FRANCE