Siemens RAPIDLab¿ 1260 system blood gas analyzer Product Usage:… — Class II medical device recall Z-0107-2014
Terminated recall by Siemens Healthcare Diagnostics Inc, reported 2013-11-06, distributed nationwide. RAPIDPoint¿ 400 Series, RAPIDPoint¿ 500, or RAPIDLab¿ 1200 Series blood gas analyzer, users can inadvertently
| Recall number | Z-0107-2014 |
|---|---|
| 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 | 2012-09-17 |
| Classified | 2013-10-29 |
| Reported by FDA | 2013-11-06 |
| Terminated | 2015-04-01 |
| Distributed | Nationwide (US) |
| Countries outside the US | AE, AR, AT, AU, BD, BE, BG, BH, BR, CH, CL, CN, CO, CZ, DE, DK, DZ, EE, EG, ES, FI, FR, GB, GR, HK, HR, HU, ID, IE, IL, IN, IQ, IS, IT, JP, KE, KR, KW, LT, LU, LV, MY, NL, NO, NZ, PH, PL, PT, QA, RO, RS, SA, SE, SG, SI, SK, TH, TR, TW, VE, VN, ZA |
| Quantity | 140 units |
Product
Siemens RAPIDLab¿ 1260 system blood gas analyzer Product Usage: RAPIDLab 1200 Systems: The Rapidlab 1200 systems are intended for in vitro diagnostic use by healthcare professionals in the quantitative testing of human whole blood. The systems can determine the following parameters: RAPIDLab 1240 pH, pC02, p02 RAPIDLab 1245 pH, pC02, p02, tHb, nBili, F02Hb, FCOHb, FMetHb, FHHb RAPIDLab 1260 pH, pC02, p02, Na+, K+, Ca++, Cl-, glucose, lactate RAPIDLab 1265 pH, pC02, p02, Na+, K+, Ca++, Cl-, glucose, lactate, tHb, nBili, F02Hb, FCOHb, FMetHb, FHHb
Reason for recall
RAPIDPoint¿ 400 Series, RAPIDPoint¿ 500, or RAPIDLab¿ 1200 Series blood gas analyzer, users can inadvertently enter a wrong patient ID on the demographics screen, which ultimately could lead to a misidentification of the sample
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-0107-2014. 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.