Health product recall

Dimension Vista - Drugs of Abuse Controls (2017-12-21)

Starting date:
December 21, 2017
Posting date:
January 12, 2018
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-65682

Affected products

Dimension Vista - Drugs of Abuse Controls

Reason

Siemens Healthcare Diagnostics has determined the Phencyclidine (PCP) analyte in Drugs of Abuse Positive Control [UDAT CON(+)] Lot 7cqp15 is recovering lower than expected. Customers may occasionally get a negative result for PCP with UDAT CON(+) Lot 7cqp15. All other analytes in the UDAT CON(+) recover appropriately.

Affected products

Dimension Vista - Drugs of Abuse Controls

Lot or serial number

7CQP15

Model or catalog number

KC515

Companies
Manufacturer

Siemens Healthcare Diagnostics Inc.

500 GBC DRIVE, MAILSTOP 514, P.O. BOX 6101

Newark

19714

Delaware

UNITED STATES