medical Class II Updated 2020-04-01

Siemens Healthcare Diagnostics, Inc. recalls Atellica CH Ethyl Alcohol, Test Code ETOH, Siemens Material

Recalled Product

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


Hazard / Issue

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

Issued by

FDA

Distribution: Nationwide (United States)
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
View official government recall

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