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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