Z-1599-2020Class II

Atellica CH Ethyl Alcohol, Test Code ETOH, Siemens Material Number (SMN) 11097501, UDI 00630414596112. The...

Name: Z-1599-2020 Atellica CH Ethyl Alcohol, Test Code ETOH, Siemens Material Number (SMN) 11097501, UDI 00630414596112. The...
Creator: Siemens Healthcare Diagnostics, Inc.
Published: 2020-02-14
License: https://open.fda.gov/license/

Siemens Healthcare Diagnostics Inc. / initiated 2020-02-14 / Terminated / root cause: manufacturing process

FDA source

Siemens Healthcare Diagnostics, Inc. began a recall of Atellica CH Ethyl Alcohol, Test Code ETOH, Siemens Material Number (SMN) 11097501, UDI 00630414596112. The product is an ethyl alcohol assay, IVD use on 2020-02-14. FDA classified it as Class II and gives the reason as "The assay may exhibit a positive bias in QC and patient results within the 10-day pack calibration interval". As of 2026-09-10, the recall status on record is Terminated, and MDM tags the root cause as manufacturing process.

Recall record

Recall number: Z-1599-2020
Classification: Class II
Status: Terminated
Initiated: 2020-02-14
Posted: 2020-02-27
Terminated: 2024-02-22
Recalling firm: Siemens Healthcare Diagnostics Inc.
Product: Atellica CH Ethyl Alcohol, Test Code ETOH, Siemens Material Number (SMN) 11097501, UDI 00630414596112. The product is an ethyl alcohol assay, IVD use.
Product code: DIC Alcohol Dehydrogenase, Specific Reagent For Ethanol Enzyme Method
Reason for recall: The assay may exhibit a positive bias in QC and patient results within the 10-day pack calibration interval.
Root cause tag: manufacturing process
FDA root cause: Under Investigation by 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.
Quantity in commerce: 1124
Distribution: 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.
Product codes and lots: All in-date lots: 190133, 190222 ***Updated 4/6/2020*** New lot added: 100066 ***Updated 9/4/20*** New lot added: 100168

Enforcement reports

One row per recalled product line

FDA enforcement reports joined to recall event Z-1599-2020
Recall number	Class	Status	Voluntary or mandated	Report date	Classified
Z-1599-2020	Class II	Terminated	Voluntary: Firm initiated	2020-04-01	2020-03-26

Product code DIC

K071811Class IIEtoh Flex Reagent Cartridge (Df22)Dade Behring, Inc. / cleared 2007-08-24

MDM coverage of this record lists here, newest first.

About this record

Sourced from the FDA device recall database and the FDA enforcement reports, both ingested from openFDA. The recall record supplies the product, the reason and the product code; the enforcement report supplies the classification. The two datasets are exported by FDA on different days, and the date above is the older of the two, so nothing on this page is newer than it says.

MDM adds the root cause tag, derived from FDA’s own root cause text, and the cross-links to the product code, the clearances named on the record and MDM coverage. Where a recall has not been joined to an enforcement report, no classification is shown.

Data as of 2026-09-30, the FDA export date for this dataset. Page last changed 2026-09-05. View this recall on fda.gov (opens on fda.gov)