Siemens Healthcare Diagnostics, Inc.: Medical Device Recall in 2020 - (Recall #: Z-1599-2020)

Updated on March 25, 2026.

See the recall detail below. You can also see other recalls from the same firm in 2020.

Data Source: FDA.

Product Description:

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

Product Classification:

Class II

Date Initiated: February 14, 2020

Date Posted: April 1, 2020

Recall Number: Z-1599-2020

Event ID: 85020

Reason for Recall:

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

Status: Terminated

Product Quantity: 1124

Code Information:

All in-date lots: 190133, 190222 ***Updated 4/6/2020*** New lot added: 100066 ***Updated 9/4/20*** New lot added: 100168

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.

Voluntary or Mandated:

Voluntary: Firm initiated