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