syngo(R) Lab Data Manager - Version VA11B and VA12A recall
syngo(R) Lab Data Manager - Version VA11B and VA12A Systems Securely consolidates data from multiple lab instruments, the LIS and Siemens StreamLAB(R)…
Why was syngo(R) Lab Data Manager - Version VA11B and VA12A recalled?
Under certain conditions the system may not perform as intended, causing the release of results to the Laboratory Information System that should have been held for manual review due to auto-verification rules or the delay/omission of result transmission to the LIS.
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?
Siemens Material Number 10800057 (Version VA11B) and 10803188 (Version VA12A)
- Product
- syngo(R) Lab Data Manager - Version VA11B and VA12A Systems Securely consolidates data from multiple lab instruments, the LIS and Siemens StreamLAB(R)…
- Recalling firm
- Siemens Healthcare Diagnostics, Inc.
- Quantity
- 262
- Distribution
- Worldwide Distribution: USA (nationwide) and internationally to Canada.
- Recall date
- December 11, 2013
- Classification
- Class II
- Status
- Terminated
- Agency
- FDA (device)