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ACL Top Analyzers – Mandatory Parameter Upgrade
- Starting date:
- June 7, 2012
- Posting date:
- September 17, 2012
- 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-23879
Recalled Products
- A. ACL Top 500 CTS
- B. ACL Top Base, Top CTS, Top 700 LAS
- C. ACL Top 700
- D. ACL Top 700 CTS
Reason
The manufacturer is conducting a mandatory parameter upgrade (P-14.8) based on two Fibrinogen-C reporting issues. Issue number one was a result of 3 customer complaints where low abnormal Fibrinogen sample reports were reporting as normal. Issue two was identified by the manufacturer during R&D where high Fibrinogen samples were reported as low.
Affected products
A. ACL Top 500 CTS
Lot or serial number
08010200 to 12062270
Model or catalog number
0000280040
Companies
- Manufacturer
- Instrumentation Laboratory Co.
B. ACL Top Base, Top CTS, Top 700 LAS
Lot or serial number
03110101 to 11111174
Model or catalog number
0000280000, 0000280020, 0000280030
Companies
- Manufacturer
- Instrumentation Laboratory Co.
C. ACL Top 700
Lot or serial number
09080100 to 12060403
Model or catalog number
0000280010
Companies
- Manufacturer
- Instrumentation Laboratory Co.
D. ACL Top 700 CTS
Lot or serial number
09120101 to 12060240
Model or catalog number
0000280050
Companies
- Manufacturer
- Instrumentation Laboratory Co.