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RAPIDPOINT 500 CARTRIDGE LACTATE (2015-08-25)
- Starting date:
- August 25, 2015
- Posting date:
- September 8, 2015
- 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-54936
Affected Products
A. RAPIDPOINT 500 CARTRIDGE LACTATE
Reason
During the manufacturing process, the sodium high calibrator value was incorrectly assigned for the Rapidpoint 500 measurement cartridge (specified serial number range only), causing a negative bias on both QC and patient samples. Cartridges within the specified range, but marked with a green dot on the box and/or cartridge, are not affected.
Affected products
A. RAPIDPOINT 500 CARTRIDGE LACTATE
Lot or serial number
2517102517 - 2519000012
Model or catalog number
10491447
10491448
10491449
10844813
Companies
- Manufacturer
-
Siemens Healthcare Diagnostics Inc.
511 Benedict Ave
Tarrytown
New York
UNITED STATES