Atellica CH Ethyl Alcohol, Test Code ETOH, Siemens Material Number (SMN) 11097501, UDI 00630414596112. The product is an ethyl alcohol assay, IVD use.
FDA Recall Z-1599-2020 · Posted 2020-02-27
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Recalling FirmSiemens Healthcare Diagnostics, Inc.
Recall StatusTerminated
Product CodeDIC
Date Initiated2020-02-14
Date Terminated2024-02-22
Product Quantity1124
Reason for Recall
The assay may exhibit a positive bias in QC and patient results within the 10-day pack calibration interval.
Firm Action
On February 11, 2020, the firm issued an Urgent Medical Device Correction to all US customers. Customers who experience the issue were instructed to perform a pack calibration every 2 days or more frequently based on the laboratory's Quality Control performance. The firm is working to address the issue in a future software version.
Customers are requested to complete and return the effectiveness check questionnaire.
If you have any questions, contact your local Siemens Healthineers technical support representative.
Root Cause
Under Investigation by firm
Distribution Pattern
Domestic distribution nationwide. Foreign distribution to Australia, Austria, Bahamas, Belgium, Canada, Curacao, Chile, Colombia, Czech Republic, Denmark, Finland, France, Germany, India, Israel, Italy, Japan, Kenya, Latvia, Mexico, Netherlands, Norway, Poland, Portugal, Slovakia, South Korea, Spain, Sweden, Switzerland, Taiwan, Turkey, U.A.E., Uruguay, United Kingdom, and Vietnam.
Related FDA 510(k) Records
Devices referenced by this recall via K-numbers.
Official Source
View FDA Recall →Source: FDA Enforcement Report / Recall database. Always confirm against the official FDA record.
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