Atellica CH 930 Analyzer (2019-08-15)

Starting date:

August 15, 2019

Posting date:

September 12, 2019

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-70955

Last updated: 2019-09-12

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  Reason
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  Affected products

Affected Products

1. ATELLICA CH 930 ANALYZER
2. Atellica CH 930 Analyzer

Reason

1. Ecstasy: The test definitions incorrectly allow for 20 day pack calibration interval instead of 15 days. Based on Siemen's investigation, there is no impact to the performance of the Ecstasy assay due to the extended pack calibration.
2. Total Protein: The test definition incorrectly allows for a 185 day lot calibration interval instead of 181 days. Based on Siemen's investigation, there is no impact to the performance of the Total Protein assay due to the extended lot calibration.
3. Rheumatoid Factor: The test definition incorrectly allows for a 30 days Onboard Stability (OBS) interval instead of 21 days. Based on Siemen's investigation, there is no impact to performance of the Rheumatoid Factor (RF) assay concentrations of approximately 7 IU/mL and 45 IU/mL due to the extended OBS. At a RF concentration of 75 IU/mL, a maximum decrease in recovery of 9% was observed due to the extended OBS.

Affected products