The Rapidlab 1265 system is a blood gas analyzer used for laboratory… — Class II medical device recall Z-1962-2015
Terminated recall by Siemens Healthcare Diagnostics, Inc, reported 2015-07-08, distributed nationwide. D50 and D51 diagnostic error codes are not functional.
| Recall number | Z-1962-2015 |
|---|---|
| Product type | Medical device |
| Classification | Class II |
| Status | Terminated |
| Voluntary or mandated | Voluntary |
| Recalling firm | Siemens Healthcare Diagnostics, Inc, East Walpole, MA, United States |
| Recall initiated | 2015-05-06 |
| Classified | 2015-07-02 |
| Reported by FDA | 2015-07-08 |
| Terminated | 2017-08-02 |
| Distributed | Nationwide (US) |
| Countries outside the US | AE, AR, AT, AU, BE, BR, CA, CH, CL, CN, CO, CZ, DE, EG, ES, FI, FR, GB, GR, HK, HR, ID, IE, IN, IS, IT, JP, KR, LT, LV, MX, MY, NL, NO, NZ, PE, PL, PT, QA, RO, SA, SE, SG, SI, SK, TH, TR, TW, VE, VN, ZA |
| Quantity | 2,713 devices |
Product
The Rapidlab 1265 system is a blood gas analyzer used for laboratory testing of blood gases, electrolytes, metabolites and CO-oximetry in arterial, venous and capillary whole blood samples.
Reason for recall
D50 and D51 diagnostic error codes are not functional.
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-1962-2015. 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.