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CLINITEK ATLAS AUTOMATED URINE CHEMISTRY SYSTEM- CONTROL STRIPS (2016-01-26)
- Starting date:
- January 26, 2016
- Posting date:
- February 8, 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-57014
Affected Products
A. CLINITEK ATLAS AUTOMATED URINE CHEMISTRY SYSTEM-POSITIVE CONTROL STRIPS
B. CLINITEK ATLAS AUTOMATED URINE CHEMISTRY SYSTEM-NEGATIVE CONTROL STRIPS
Reason
There is a potential issue when entering the CLINITEK Atlas Control lot information into the CLINITEK Novus analyzer for the bottle lot numbers P0001105, P0003115, N0006115. This is due to a missing alpha character at the end of the lot number on the control bottles, for example: lot P0001105 instead of P0001105X.
Affected products
A. CLINITEK ATLAS AUTOMATED URINE CHEMISTRY SYSTEM-POSITIVE CONTROL STRIPS
Lot or serial number
- P0001105
- P0003115
Model or catalog number
10311124
Companies
- Manufacturer
-
Siemens Healthcare Diagnostics Inc.
511 Benedict Ave
Tarrytown
10591
New York
UNITED STATES
B. CLINITEK ATLAS AUTOMATED URINE CHEMISTRY SYSTEM-NEGATIVE CONTROL STRIPS
Lot or serial number
N0006115
Model or catalog number
10311135
Companies
- Manufacturer
-
Siemens Healthcare Diagnostics Inc.
511 Benedict Ave
Tarrytown
10591
New York
UNITED STATES