Z-1599-2020 Class II Terminated
FDA device recall Z-1599-2020 was initiated by Siemens Healthcare Diagnostics, Inc. on February 14, 2020 and is designated Class II. Reason for recall: The assay may exhibit a positive bias in QC and patient results within the 10-day pack calibration interval. The recall status is terminated (terminated February 22, 2024). Affected quantity: 1124.
Recall Details
- Product Type
- Devices
- Report Date
- April 1, 2020
- Initiation Date
- February 14, 2020
- Termination Date
- February 22, 2024
- Voluntary/Mandated
- Voluntary: Firm initiated
- Product Quantity
- 1124
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.
Reason for Recall
The assay may exhibit a positive bias in QC and patient results within the 10-day pack calibration interval.
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.
Code Information
All in-date lots: 190133, 190222 ***Updated 4/6/2020*** New lot added: 100066 ***Updated 9/4/20*** New lot added: 100168