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Health product recall

RAPIDlab 1265 System - Analyzer (2015-05-06)

Starting date:
May 6, 2015
Posting date:
June 1, 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-53529

Recalled Products

  1. RAPIDlab 1265 System - Analyzer

Reason

During some internal testing at Siemens, it was discovered that the D50 (glucose sensor) and D51 (lactate sensor) error codes were not functioning on the RAPIDLab 1260 and RAPIDLab 1265 instruments. Glucose and lactate sensors that are not completely seated with the contacts on the instrument should alert the operator with a D50 (glucose sensor) error or a D51 (lactate sensor) error.

Affected products

A. RAPIDlab 1265 System - Analyzer

Lot or serial number
  • 14532
  • 14588
  • 14768
  • 16314
Model or catalog number

Not applicable

Companies
Manufacturer
Siemens Healthcare Diagnostics Inc.
511 Benedict Ave
Tarrytown
New York
UNITED STATES