Rapidpoint 405, Rapidlab 1265 System Analyzers and Rapidpoint 500 System - Main Unit (2015-01-07)

Starting date:

January 7, 2015

Posting date:

January 21, 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-43383

• Reason
• Affected products

A) Rapidpoint 405 System - Analyzer
B) Rapidlab1265 System - Analyzer
C) Rapidpoint 500 System - Main Unit

Reason

Siemens Healthcare Diagnostics is sending an urgent field safety notice to customers to remind them that the neonatal bilirubin (nBili) parameter on the Rapidpoint 405, Rapidpoint 500, Rapidlab 1245 and Rapidpoint 1265 analyzers may have increased variability when the nBili concentration is >12 mg/dl (205micro mol/l) and the THb concentration exceeds the upper reportable range of >25 g/dl (15.5mmol/l). When this occurs, the analyzer may report nBili result that is higher or lower than expected.

Affected products