Z-0205-2020 Class II Terminated
FDA device recall Z-0205-2020 was initiated by Siemens Healthcare Diagnostics, Inc. on August 15, 2019 and is designated Class II. Reason for recall: Issues Scanning New Reagent Lot Test Definition on the Atellica IM 1300 Analyzer and Atellica IM 1600 Analyzer SW V 1.19.0 and 1.19.2 The recall status is terminated (terminated May 5, 2022). Affected quantity: 166 total US: 15; OUS:151.
Recall Details
- Product Type
- Devices
- Report Date
- October 30, 2019
- Initiation Date
- August 15, 2019
- Termination Date
- May 5, 2022
- Voluntary/Mandated
- Voluntary: Firm initiated
- Product Quantity
- 166 total US: 15; OUS:151
Product Description
Atellica IM 1600 Analyzer, (SW) version V1.19.0 and V1.19.2 Siemens Material Number (SMN): 11066000
Reason for Recall
Issues Scanning New Reagent Lot Test Definition on the Atellica IM 1300 Analyzer and Atellica IM 1600 Analyzer SW V 1.19.0 and 1.19.2
Distribution Pattern
Nationwide Foreign: Argentina Australia Bangladesh Belgium Brazil Colombia Dominican Republic Finland France Germany Greece Italy Japan Latvia Mexico Netherlands P.R. China Republic Korea Singapore Spain Switzerland Thailand United Kingdom Vietnam
Code Information
(SW) version V1.19.0 and V1.19.2 UDI: 00630414002026