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

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  Reason
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  Affected products

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