syngo Lab Data Manager — Class II medical device recall Z-1944-2014
Terminated recall by Siemens Healthcare Diagnostics, Inc., reported 2014-07-09, distributed nationwide. Certain configuration parameters may cause the reference ranges to not hold results as expected and release th
| Recall number | Z-1944-2014 |
|---|---|
| Product type | Medical device |
| Classification | Class II |
| Status | Terminated |
| Voluntary or mandated | Voluntary |
| Recalling firm | Siemens Healthcare Diagnostics, Inc., Newark, DE, United States |
| Recall initiated | 2014-05-20 |
| Classified | 2014-06-30 |
| Reported by FDA | 2014-07-09 |
| Terminated | 2015-08-10 |
| Distributed | Nationwide (US) |
| Countries outside the US | AU, BE, CA, CZ, DE, DK, ES, FI, FR, GB, IT, JP, NL, PT, SG, SK |
| Quantity | 336 |
Product
syngo Lab Data Manager, SMN 10800057, 10803189, and 10804573.
Reason for recall
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.
Machine access
This record, with every extracted code, the verbatim FDA record and provenance, is available from the recall API: GET https://api.data.aroqon.com/v1/recalls/Z-1944-2014. Look up any UPC, UDI, NDC or lot with /v1/recalls/lookup?code=…. API docs · free and paid keys.
Source: U.S. Food and Drug Administration enforcement report via openFDA (CC0). Structured by Data Foundry (recall-structuring@2); last changed 2026-09-26. Not affiliated with or endorsed by FDA. Not medical or legal advice.