ADIVA 120 System - DIFF TIMEpac, ADVIA 2120I Hematology System - DIFF TIMEpac and ADVIA 2120 Hematology System - DIFF TIMEpac (2018-04-10)
- Starting date:
- April 10, 2018
- Posting date:
- May 1, 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-66636
Affected products
A. ADVIA 120 SYSTEM- DIFF TIMEPAC
B. ADVIA 2120I HEMATOLOGY SYSTEM- DIFF TIMEPAC
C. ADVIA 2120 HEMATOLOGY SYSTEM- DIFF TIMEPAC
Reason
Platelet Clump flags (plt-clm) are generated in the Perox channel of the ADVIA 120/2120/2120i Hematology System while running CBC/DIFF (Complete Blood Count / Differential) whole blood samples with DIFF timepac Perox 1 reagent lot # 57211, in samples without platelet clumps. Platelet results will be flagged if the clump count is greater than 300, directing the user to investigate the sample.
Affected products
A. ADVIA 120 SYSTEM- DIFF TIMEPAC
Lot or serial number
73839
74264
Model or catalog number
10312270
Companies
- Manufacturer
-
Siemens Healthcare Diagnostics Inc.
511 Benedict Ave
Tarrytown
10591
UNITED STATES
B. ADVIA 2120I HEMATOLOGY SYSTEM- DIFF TIMEPAC
Lot or serial number
73839
74264
Model or catalog number
10312270
Companies
- Manufacturer
-
Siemens Healthcare Diagnostics Inc.
511 Benedict Ave
Tarrytown
10591
UNITED STATES
C. ADVIA 2120 HEMATOLOGY SYSTEM- DIFF TIMEPAC
Lot or serial number
73839
74264
Model or catalog number
10312270
Companies
- Manufacturer
-
Siemens Healthcare Diagnostics Inc.
511 Benedict Ave
Tarrytown
10591
UNITED STATES