Rapidpoint 500 system - Lactate Measurement Cartridges (2014-05-30)

Starting date:

May 30, 2014

Posting date:

June 19, 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-40059

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  Reason
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  Affected products

Recalled Products

Rapidpoint 500 system - Lactate Measurement Cartridges

Reason

Siemens healthcare diagnostics has received several reports from customers of one or more electrolyte parameters (e.g., Na+, Ca++, K+, Cl-) reporting a " ? " error code when AQC, QC, or CVM is run on the Rapid point 500 blood gas analyzer. When exhibited, the tissue is usually seen during level 1 QC/AQC, Level 1 CVM, and sometimes Level 2 CVM testing. This issue has also been observed on a small number of patient samples. This issue impacts only Rapidpoint 500 measurement cartridges P/NS 10491447, 10491448, 10491449, and 10844813. Siemens has observed this issue with Rapidpoint 500 measurement cartridges with serial numbers up to 2412705915, however, not all these cartridges will exhibit this behavior. The issue does not impact Rapidpoint 400 or Rapidpoint 405 measurement cartridges.

Affected products