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