(1) Atellica Data Manager software version 1.0 Siemens Material… — Class II medical device recall Z-2438-2020
Terminated recall by Siemens Healthcare Diagnostics, Inc., reported 2020-07-08, distributed nationwide. Unexpected interface driver behavior identified (QC) Results May Be Assigned to an Incorrect Control Lot Numbe
| Recall number | Z-2438-2020 |
|---|---|
| Product type | Medical device |
| Classification | Class II |
| Status | Terminated |
| Voluntary or mandated | Voluntary |
| Recalling firm | Siemens Healthcare Diagnostics, Inc., Tarrytown, NY, United States |
| Recall initiated | 2020-05-15 |
| Classified | 2020-06-26 |
| Reported by FDA | 2020-07-08 |
| Terminated | 2021-05-18 |
| Distributed | Nationwide (US) |
| Countries outside the US | AE, AR, AU, BE, BR, BS, CL, CO, CZ, DE, EG, ES, GB, GR, HU, IN, IT, KW, LT, LV, MX, MY, OM, PE, PL, PT, QA, SA, SE, SG, TH, TR, ZA |
| Quantity | 70 units |
| UPC / GTIN / UDI-DI | 00630414234946 |
Product
(1) Atellica Data Manager software version 1.0 Siemens Material Number (SMN): 11314237 (2) Atellica Data Manager software version 1.1 Siemens Material Number (SMN): 11316888 Product Usage: are clinical laboratory information modules which consolidate test orders and test results, provide test ordering and priority routing information to automation, apply rules to test orders and auto-verification rules for test results, and provide integrated management of quality control of test system.
Reason for recall
Unexpected interface driver behavior identified (QC) Results May Be Assigned to an Incorrect Control Lot Number, and lead to the reporting of erroneous patient results if the QC failed but appeared to be passing and the issue is not detected during QC 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-2438-2020. 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.