This page has been archived on the Web

Information identified as archived is provided for reference, research or recordkeeping purposes. It is not subject to the Government of Canada Web Standards and has not been altered or updated since it was archived. Please contact us to request a format other than those available.

Health product recall

m2000sp Instrument, G-series and E-series (2015-12-14)

Starting date:
December 14, 2015
Posting date:
January 7, 2016
Type of communication:
Medical Device Recall
Subcategory:
Medical Device
Hazard classification:
Type III
Source of recall:
Health Canada
Issue:
Medical Devices
Audience:
General Public, Healthcare Professionals, Hospitals
Identification number:
RA-56550

Affected Products

A. m2000sp Instrument, G-series and E-series

Reason

Investigation at Abbott Molecular identified that an incorrect type of tip adapter (type D) could have been installed on m2000sp instrument during a service visit on or after august 14, 2015. This is because two lots of Abbott Molecular PN 30084426 (lots 76258007 and 77228007) were shipped with type D tip adapters rather than the required type B adapters.

Affected products

A. m2000sp Instrument, G-series and E-series

Lot or serial number
  • 10378
  • 10417
  • 10472
  • 10621
  • 10762
  • 4123-G SERIES
Model or catalog number
  • 9K14-01
  • 9K14-02
Companies
Manufacturer

Abbott Molecular Inc.

1300 E. Touhy Ave.

Des Plaines

60018

Illinois

UNITED STATES