Atellica IM 1600 Analyzer recall
Atellica IM 1600 Analyzer, (SW) version V1.19.0 and V1.19.2 Siemens Material Number (SMN): 11066000
Why was Atellica IM 1600 Analyzer 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
What should I do if I have this product?
Review the official FDA enforcement record for current instructions.
What to do with a recalled product: refunds, receipts, safe disposal and how to report a problem.
Is my product affected?
Compare the item in your hand with every identifier below from the official FDA record. Only products that match the listed product and lot, UPC or model codes are part of this recall.
Which lot codes, UPCs or models are affected?
(SW) version V1.19.0 and V1.19.2 UDI: 00630414002026
- Product
- Atellica IM 1600 Analyzer, (SW) version V1.19.0 and V1.19.2 Siemens Material Number (SMN): 11066000
- Recalling firm
- Siemens Healthcare Diagnostics, Inc.
- Quantity
- 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
- Recall date
- October 30, 2019
- Classification
- Class II
- Status
- Terminated
- Agency
- FDA (device)