—#179926

Product

Atellica CH Ethyl Alcohol, Test Code ETOH, Siemens Material Number (SMN) 11097501, UDI 00630414596112. The product is an ethyl alcohol assay, IVD use.

FDA product code: DIC — Alcohol Dehydrogenase, Specific Reagent For Ethanol Enzyme Method
Device class: Class 2
Medical specialty: Clinical Toxicology
510(k) numbers: K071811
Affected lot / code info: All in-date lots: 190133, 190222 ***Updated 4/6/2020*** New lot added: 100066 ***Updated 9/4/20*** New lot added: 100168

Why it was recalled

The assay may exhibit a positive bias in QC and patient results within the 10-day pack calibration interval.

Root cause (FDA determination)

Under Investigation by firm

Action the firm took

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.

Recalling firm

Firm: Siemens Healthcare Diagnostics, Inc.
Address: 511 Benedict Ave, Tarrytown, New York 10591-5005

Distribution

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.

Timeline

Recall initiated: 2020-02-14
Posted by FDA: 2020-02-27
Terminated: 2024-02-22
Status: —

Source: openFDA Device Recall endpoint. Recall record ID #179926. The FDA issues recall classifications as health-hazard assessments, not legal findings; for legal claims consult a licensed attorney.