Class II — Siemens Healthcare Diagnostics Inc
| Recalling firm | SIEMENS HEALTHCARE DIAGNOSTICS INC. |
|---|---|
| Registered facility | View this company's 12 registered facilities → (openFDA recall records do not name a specific facility) |
| Classification | Class II |
| Status | Terminated |
| Reason | 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 |
| 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 |
| Quantity | 140 units |
| Distribution | Worldwide Distribution - USA Nationwide and in the countries of Algeria, Argentina, Australia, Austria, Bahrain, Bangladesh, Belgium, Bosnia Herzeg., Botswana, Brazil, Brunei, Bulgaria, Chile, Colombia, Croatia, Czech Republic, Denmark, Egypt, Estonia, Finland, France, Fren.Polynesia, Germany, Greece, Hong Kong, Hungary, Iceland, India, Indonesia, Iraq, Ireland, Israel, Italy, Ivory Coast, Japan, … |
| Initiated | 2012-09-17 |
| Classified | 2013-10-29 |
| Terminated | 2015-04-01 |
| Recall number | Z-0107-2014 |
| Initiation | Voluntary: Firm initiated |
Source: U.S. FDA via openFDA (opens in a new tab) (device registration & enforcement). Data as of 2026-10-06. Verify this recall record at FDA → (opens in a new tab)
Cite this record
RegWarden. “Class II recall — Siemens Healthcare Diagnostics Inc (Z-0107-2014).” Compiled from U.S. FDA public records (openFDA; FDA Data Dashboard). Data as of 2026-10-06. https://regwarden.com/recall/66166/
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