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Architect C16000/C4000 System - Processing Modules (2017-10-04)
- Starting date:
- October 4, 2017
- Posting date:
- October 13, 2017
- Type of communication:
- Medical Device Recall
- Subcategory:
- Medical Device
- Hazard classification:
- Type II
- Source of recall:
- Health Canada
- Issue:
- Medical Devices
- Audience:
- Healthcare Professionals, General Public, Hospitals
- Identification number:
- RA-64848
Affected products
- ARCHITECT C 16000 - PROCESSING MODULE
- ARCHITECT C4000 SYSTEM - PROCESSING MODULE
Reason
Abbott has become aware that the Peristaltic Head tubing placed on the Architect has the possibility to leak due to a manufacturing issue associated with the tubing connector. This tubing was not original to Architect, but installed during a service visit that occurred between June 16, 2017 and July 20, 2017. Peristaltic Head tubing is used on Architect clinical chemistry instruments as part of waste aspiration during the cuvette cleaning process.
Affected products
A. ARCHITECT C 16000 - PROCESSING MODULE
Lot or serial number
- s/n: C1600144
- s/n: C1600819
- s/n: C1600859
- s/n: C1600976
Model or catalog number
03L77-01
Companies
- Manufacturer
-
Abbott Laboratories Diagnostics Division
100 ABBOTT PARK ROAD
ABBOTT PARK
60064
Illinois
UNITED STATES
B. ARCHITECT C4000 SYSTEM - PROCESSING MODULE
Lot or serial number
- s/n: C460943
- s/n: C461550
Model or catalog number
02P24-01
Companies
- Manufacturer
-
Abbott Laboratories Diagnostics Division
100 ABBOTT PARK ROAD
ABBOTT PARK
60064
Illinois
UNITED STATES