Atellica IM 1600 Analyzer, (SW) version V1.19.0 and V1.19.2 Siemens Material Number (SMN): 11066000
Reported: October 30, 2019 Initiated: August 15, 2019 #Z-0205-2020
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
Details
- Recalling Firm
- Siemens Healthcare Diagnostics, Inc.
- Units Affected
- 166 total US: 15; OUS:151
- Distribution
- 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
- Location
- Tarrytown, NY
Frequently Asked Questions
What product was recalled? ▼
Atellica IM 1600 Analyzer, (SW) version V1.19.0 and V1.19.2 Siemens Material Number (SMN): 11066000. Recalled by Siemens Healthcare Diagnostics, Inc.. Units affected: 166 total US: 15; OUS:151.
Why was this product recalled? ▼
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
Which agency issued this recall? ▼
This recall was issued by the FDA Devices on October 30, 2019. Severity: Moderate. Recall number: Z-0205-2020.
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