Atellica CH Ethyl Alcohol (2020-02-19)
- Starting date:
- February 19, 2020
- Posting date:
- March 6, 2020
- 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-72497
Last updated: 2020-03-10
Affected Products
Atellica CH Ethyl Alcohol
Reason
Siemens Healthcare Diagnostics Inc. investigation has confirmed that the Atellica CH ETOH assay may exhibit a positive bias in QC and patient results within the 10-day pack calibration interval. When a positive bias is observed, the magnitude is similar for both quality control and patient results. The product issue potentially affects all Atellica CH ETOH reagent lots. Based on Siemens’ internal investigation, not all laboratories are experiencing this issue. Siemens’ investigation has shown that when this issue occurs, an average positive bias of 7 mg/dl (1.5 mmol/L) with a maximum bias of 11 mg/dL (2.4 mmol/L) at an ethanol concentration of approximately 20.6 mg/dL (4.5 mmol/L) was observed by day 10 of the pack calibration interval. Samples with an ethanol concentration of approximately 200 mg/dL (43.4 mmol/L) met expected performance criteria across the 10-day pack calibration interval. Siemens is working to address this issue in a future software version.
Affected products
Atellica CH Ethyl Alcohol
Lot or serial number
- 180379
- 190033
- 190222
Model or catalog number
11097501
Companies
- Manufacturer
-
Siemens Healthcare Diagnostics Inc.
511 Benedict Ave
Tarrytown
10591
New York
UNITED STATES