This page has been archived on the Web
Information identified as archived is provided for reference, research or recordkeeping purposes. It is not subject to the Government of Canada Web Standards and has not been altered or updated since it was archived. Please contact us to request a format other than those available.
ACL Top Family Devices (2014-06-03)
- Starting date:
- June 3, 2014
- Posting date:
- July 3, 2014
- Type of communication:
- Medical Device Recall
- Subcategory:
- Medical Device
- Hazard classification:
- Type II
- Source of recall:
- Health Canada
- Issue:
- Medical Devices
- Audience:
- General Public, Healthcare Professionals, Hospitals
- Identification number:
- RA-40303
Recalled Products
A) ACL Top 500 CTS
B) ACL Top, ACL Top CTS, ACL Top 700 LAS
C) ACL Top 700
D) ACL Top 700 CTS
E) ACL Top 300 CTS
Reason
Potential for a sample misidentification on the ACL TOP family that only occurs following a specific set of steps combined with inability of the system to read a specific sample rack barcode.
Affected products
A) ACL Top 500 CTS
Lot or serial number
SN 08010100 to 14052901
Model or catalog number
0000280040
Companies
- Manufacturer
-
Instrumentation Laboratory Co.
180 Hartwell Road
Bedford
01730-2443
Massachusetts
UNITED STATES
B) ACL Top, ACL Top CTS, ACL Top 700 LAS
Lot or serial number
SN 03110101 to 11111174
SN 06020101 to 10080662
SN 08120100 to 14050198
Model or catalog number
0000280000
0000280020
0000280030
Companies
- Manufacturer
-
Instrumentation Laboratory Co.
180 Hartwell Road
Bedford
01730-2443
Massachusetts
UNITED STATES
C) ACL Top 700
Lot or serial number
SN 09080100 to 14050732
Model or catalog number
0000280010
Companies
- Manufacturer
-
Instrumentation Laboratory Co.
180 Hartwell Road
Bedford
01730-2443
Massachusetts
UNITED STATES
D) ACL Top 700 CTS
Lot or serial number
SN 09120101 to 14050368
Model or catalog number
0000280050
Companies
- Manufacturer
-
Instrumentation Laboratory Co.
180 Hartwell Road
Bedford
01730-2443
Massachusetts
UNITED STATES
E) ACL Top 300 CTS
Lot or serial number
SN 11110101 to 14051302
Model or catalog number
0000280060
Companies
- Manufacturer
-
Instrumentation Laboratory Co.
180 Hartwell Road
Bedford
01730-2443
Massachusetts
UNITED STATES