Alinity i Processing Module (2018-12-26)
- Starting date:
- December 26, 2018
- Posting date:
- January 23, 2019
- 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-68844
Affected products
Alinity i Processing Module
Reason
Abbott has identified an issue with the Alinity I gear pump assembly (part number a 30108552-01) resulting in foaming/bubbling out of the bottle reservoir for concentrated wash buffer and an unexpected amount of dried residue of buffer. The foaming/bubbling is a result of an improper calibration of the pump's operating speed.
Affected products
Alinity i Processing Module
Lot or serial number
- Ai01457
- Ai01459
- Ai01001 to Ai01455
Model or catalog number
03R65-01
Companies
- Manufacturer
-
Abbott GmbH and Co. K.G.
Max Planck Ring 2
Wiesbaden
65205
GERMANY