Stratus¿ CS STAT Fluorometric Analyzer-microprocessor-controlled… — Class II medical device recall Z-2525-2016
Terminated recall by Siemens Healthcare Diagnostics Inc, reported 2016-08-17. Software defect, where either an Above Assay Range or an inaccurate value could potentially be reported, in th
| Recall number | Z-2525-2016 |
|---|---|
| Product type | Medical device |
| Classification | Class II |
| Status | Terminated |
| Voluntary or mandated | Voluntary |
| Recalling firm | Siemens Healthcare Diagnostics Inc, Norwood, MA, United States |
| Recall initiated | 2016-06-22 |
| Classified | 2016-08-11 |
| Reported by FDA | 2016-08-17 |
| Terminated | 2018-11-29 |
| Countries outside the US | AE, AT, AU, BD, BE, CA, CH, CN, CO, CZ, DE, DK, DZ, ES, FI, FR, GB, GR, HR, IE, IN, IT, JP, LT, MX, MY, PL, PT, RO, SA, SE, SI, TR, TW, ZA |
| Quantity | 977 units |
| Reason classes | potency, software |
Product
Stratus¿ CS STAT Fluorometric Analyzer-microprocessor-controlled instrument that measures certain analytes in body fluids for in vitro diagnostic use. Assays include ~hCG, CRP, CKMB, cTNI, D-Dimer, Myoglobin, and pBNP. SMN: 10444834, 10453531
Reason for recall
Software defect, where either an Above Assay Range or an inaccurate value could potentially be reported, in the Stratus CS Acute Care Diagnostics System regarding TestPak calibration and quality control (QC) status when a TestPak is due to expire within 48 hours.
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-2525-2016. 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.