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Rapidpoint 405 System - Analyzer (2014-09-03)
- Starting date:
- September 3, 2014
- Posting date:
- September 11, 2014
- 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-41331
Recalled Products
Rapidpoint 405 System – Analyzer
Reason
Siemens healthcare diagnostics has confirmed an error in the v3.9 software which may affect Na+ results on your Automatic Quality Control (AQC) cartridge (SMN 10310323). Level 2 & 3 Na+ AQC values may be elevated, but within the published target ranges. The published AQC target ranges for all other analytes are unaffected. Manual quality controls are also unaffected. This software issue has been addressed with a manufacturing change to the AQC cartridges beginning with AQC cartridge lot number AQC/1774 (serial number 1403793825). AQC cartridges used on the Rapidpoint 500 and Rapidlab 1200 systems are not affected.
Affected products
Rapidpoint 405 System – Analyzer
Lot or serial number
10896
10898
Model or catalog number
RAPIDPOINT 405
Companies
- Manufacturer
-
Siemens Healthcare Diagnostics Inc.
511 Benedict Ave.
Tarrytown
10591
New York
UNITED STATES