ADVIA 120, 21201 and 2120 Hematology System (2020-03-06)
- Starting date:
- March 6, 2020
- Posting date:
- April 16, 2020
- 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-72749
Last updated:
Affected Products
- ADVIA 120 System - CBC TIMEPAC
- ADVIA 120 System - CN-Free CBC TIMEPAC
- ADVIA 2120I Hematology System CBC TIMEPAC
- ADVIA 2120I Hematology System - CNFREE CBC TIMEPAC
- ADVIA 2120 Hematology System - CBC TIMEPAC
- ADVIA 2120 Hematology System - CNFREE CBC TIMEPAC
Reason
Siemens Healthcare Diagnostics Inc. has confirmed that certain lots of ADVIA 120/2120/2120I CBC TIMEPACS and CN-FREE CBC TIMEPACS may exhibit an elevated % baso count, which may lead to unnecessary flagging and manual slide review. Whenever such flags are triggered, the user should review the results and take the action recommended. Siemens has confirmed that certain lots of baso reagent contained within the timepacs may cause a shift of at least 1.5 times higher than expected for % baso.
Affected products
A. ADVIA 120 System - CBC TIMEPAC
Lot or serial number
- 9705
- 24602
Model or catalog number
- 10312269
Companies
- Manufacturer
-
Siemens Healthcare Diagnostics Inc.
511 Benedict Ave
Tarrytown
10591
New York
UNITED STATES
B. ADVIA 120 System - CN-Free CBC TIMEPAC
Lot or serial number
- 10421
- 10422
- 24603
- 38722
- 44385
- 88530
Model or catalog number
- 10341169
Companies
- Manufacturer
-
Siemens Healthcare Diagnostics Inc.
511 Benedict Ave
Tarrytown
10591
New York
UNITED STATES
C. ADVIA 2120I Hematology System CBC TIMEPAC
Lot or serial number
- 9705
- 24602
Model or catalog number
- 10312269
Companies
- Manufacturer
-
Siemens Healthcare Diagnostics Inc.
511 Benedict Ave
Tarrytown
10591
New York
UNITED STATES
D. ADVIA 2120I Hematology System - CNFREE CBC TIMEPAC
Lot or serial number
- 10421
- 10422
- 24603
- 38722
- 44385
- 88530
Model or catalog number
- 10341169
Companies
- Manufacturer
-
Siemens Healthcare Diagnostics Inc.
511 Benedict Ave
Tarrytown
10591
New York
UNITED STATES
E. ADVIA 2120 Hematology System - CBC TIMEPAC
Lot or serial number
- 9705
- 24602
Model or catalog number
- 10312269
Companies
- Manufacturer
-
Siemens Healthcare Diagnostics Inc.
511 Benedict Ave
Tarrytown
10591
New York
UNITED STATES
F. ADVIA 2120 Hematology System - CNFREE CBC TIMEPAC
Lot or serial number
- 10421
- 10422
- 24603
- 38722
- 44385
- 88530
Model or catalog number
- 10341169
Companies
- Manufacturer
-
Siemens Healthcare Diagnostics Inc.
511 Benedict Ave
Tarrytown
10591
New York
UNITED STATES