Alinity C & I Processing Module (2019-09-19)
- Starting date:
- September 19, 2019
- Posting date:
- November 15, 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-71627
Last updated: 2019-11-15
Produits touchés
A. Alinity C Processing Module
B. Alinity I Processing Module
Reason
The development of environmental stress on the bulk solution level sensor can cause cracks. Cracks can allowair to enter the fluid line, which may result either a failure to dispense or an incomplete dispense of the bulk solution on Alinity i and Alinity c.
Affected products
A. Alinity C Processing Module
Lot or serial number
More than 10 numbers, contact manufacturer.
Model or catalog number
- 03R67-01
Companies
- Manufacturer
-
Abbott GmbH and Co. K.G.
Max Planck Ring 2
Wiesbaden
65205
GERMANY
B. Alinity I Processing Module
Lot or serial number
More than 10 numbers, contact manufacturer.
Model or catalog number
03R65-01
Companies
- Manufacturer
-
Abbott GmbH and Co. K.G.
Max Planck Ring 2
Wiesbaden
65205
GERMANY