Health product recall

HEMA-TEK Slide Stainer - Stain Pak - Modified Wright's Stain and Wright-Giemsa Stain (2018-08-13)

Starting date:
August 13, 2018
Posting date:
August 31, 2018
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-67618

Affected products

A. HEMA-TEK Slide Stainer - Stain Pak - Modified Wright's Stain
B. HEMA-TEK Slide Stainer - Stain Pak - Wright-Giemsa Stain

Reason

Manufacturer communication indicating that the lots of stain included in the notification may form precipitate on a slide during the staining process. This precipitation may make it more difficult to successfully perform peripheral blood microscopy procedures. This problem has been linked to a single lot of raw material used in manufacturing.

Affected products

A. HEMA-TEK Slide Stainer - Stain Pak - Modified Wright's Stain

Lot or serial number

433521
439679
442400
447882

Model or catalog number

06689653

Companies
Manufacturer
Siemens Healthcare Diagnostics Inc.
511 Benedict Ave
Tarrytown
10591
New York
UNITED STATES

B. HEMA-TEK Slide Stainer - Stain Pak - Wright-Giemsa Stain

Lot or serial number

439684
442399
447880
447881

Model or catalog number

01178588

Companies
Manufacturer
Siemens Healthcare Diagnostics Inc.
511 Benedict Ave
Tarrytown
10591
New York
UNITED STATES