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Siemens Healthcare Diagnostics, Inc. recalls Atellica CH Ethyl Alcohol, Test Code ETOH, Siemens Material Number (SMN) 11097501, UDI 00630414596112. The product is an
Recalled April 1, 2020 · FDA recall Z-1599-2020 · Siemens Healthcare Diagnostics
Hazard
The assay may exhibit a positive bias in QC and patient results within the 10-day pack calibration interval. · FDA Class II
Units
1124
Sold at
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.
Description
The assay may exhibit a positive bias in QC and patient results within the 10-day pack calibration interval.
Product
Atellica CH Ethyl Alcohol, Test Code ETOH, Siemens Material Number (SMN) 11097501, UDI 00630414596112. The product is an ethyl alcohol assay, IVD use.
Manufacturer(s)
Siemens Healthcare Diagnostics, Inc.
Source: U.S. Food and Drug Administration. Official recall notice on fda.gov →