Health product recall

Automate 2550 and 1250, Aliquotter Tip Present Sensor (2018-01-16)

Starting date:
January 16, 2018
Posting date:
February 1, 2018
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-65884

Affected products

Automate 2550 and 1250, Aliquotter Tip Present Sensor

Reason

Beckman Coulter has identified a rare potential issue with the tip present sensor within the robot of the aliquoter module. There has been one report of a misaligned sensor in an automate system, which resulted in the system processing samples without pipette tips. A small number of samples were subject to cross-contamination and were sent to the error rack prior to analysis. In this particular case, the system gave no external sign of a misaligned tip present sensor.

Affected products

Automate 2550 and 1250, Aliquotter Tip Present Sensor

Lot or serial number
  • ODL25255-4344
  • ODL25255-4546
Model or catalog number
  • ODL25125
  • ODL25255
Companies
Manufacturer

Beckman Coulter, Inc.

250 S. Kraemer Blvd.

Brea

92821

California

UNITED STATES