syngo Lab Data Manager recall
syngo Lab Data Manager, SMN 10800057, 10803189, and 10804573.
Why was syngo Lab Data Manager recalled?
Certain configuration parameters may cause the reference ranges to not hold results as expected and release them to the Laboratory Information System (LIS) that should have been held for manual review.
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?
syngo Lab Data Manager Application Software versions VA11B, VA12A, and VA12B
- Product
- syngo Lab Data Manager, SMN 10800057, 10803189, and 10804573.
- Recalling firm
- Siemens Healthcare Diagnostics, Inc.
- Quantity
- 336
- Distribution
- Worldwide Distribution. US Nationwide, Canada, Australia, Belgium, Czech Republic, Germany, Denmark, Finland, France, United Kingdom, Italy, Netherlands, Portugal, Slovakia, Singapore, Japan, and Spain.
- Recall date
- July 9, 2014
- Classification
- Class II
- Status
- Terminated
- Agency
- FDA (device)