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Health product recall

Clinitek Atlas Automated Urine Chemistry System

Starting date:
August 16, 2017
Posting date:
September 11, 2017
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-64482

Reason

Reports of AC-03 errors (wet calibration failures) regarding specific Clinitek Atlas Reagent Pak Lots. This issue is intermittent, and not all reagent paks are affected.

Affected products

Clinitek Atlas Automated Urine Chemistry System

Lot or serial number

More than 10 numbers, contact manufacturer

Model or catalog number

10311120

Companies

Manufacturer

Siemens Healthcare Diagnostics Inc.

511 Benedict Ave

Tarrytown

10591

UNITED STATES