Health product recall

Alinity ci-series System Control Module (2019-06-13)

Starting date:
June 13, 2019
Posting date:
June 28, 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-70321

Last updated: 2019-06-28

Affected Products

Alinity ci-series System Control Module

Reason

Abbott has identified an issue with all on-market versions of Alinity ci-series Software where re-use of reaction vessels (RVs) may occur after a system Stop. This issue only occurs if the system is transitioned from Processing to Stopped to Idle and has the potential to cause incorrect results.

Affected products

Alinity ci-series System Control Module

Lot or serial number

All lots.

Model or catalog number

03R70-01

Companies
Manufacturer
Abbott GMBH & Co. K.G.
MAX PLANCK RING 2
WIESBADEN
65205
GERMANY