Analyzer and Atellica IM 1600 Analyzer system for in recall
Analyzer and Atellica IM 1600 Analyzer system for in vitro diagnostic testing of clinical specimens.
Why was Analyzer and Atellica IM 1600 Analyzer system for in recalled?
When more than one immunoassay analyzer is connected to a single solution system, reporting and conversion factors may not be applied to all analyzers
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?
UDI 00630414002026
- Product
- Analyzer and Atellica IM 1600 Analyzer system for in vitro diagnostic testing of clinical specimens.
- Recalling firm
- Siemens Healthcare Diagnostics, Inc.
- Quantity
- N/A
- Distribution
- FL and France Spain Sweden United Kingdom Germany
- Recall date
- May 9, 2018
- Classification
- Class II
- Status
- Terminated
- Agency
- FDA (device)