FDA Device recall Z-2815-2015
Siemens RAPIDPoint 500 Measurement Cartridge Lactate (250) tests Part Number: 10491447 Product Usage: The RAPIDPoint 500 system is designed…
- FDA Device
- Class II
- terminated
- Published 2015-09-30
On 2015-09-30 the FDA classified a Class II recall of Siemens RAPIDPoint 500 Measurement Cartridge Lactate (250) tests Part Number: 10491447 Product Usage: The RAPIDPoint 500 system is designed… by Siemens Healthcare Diagnostics, citing RAPIDPoint 500 measurement cartridge serial numbers 2517102517 through 2519000012, negative sodium bias on both QC and patient results.
Read the official FDA Device notice
| Agency | FDA Device |
|---|---|
| Recall number | Z-2815-2015 |
| Classification | Class II |
| Status | terminated |
| Initiated | 2015-08-24 |
| Published | 2015-09-30 |
| Last updated | 2026-09-13 11:53 UTC |
| Company | Siemens Healthcare Diagnostics |
| Distribution | US |
Product
Siemens RAPIDPoint 500 Measurement Cartridge Lactate (250) tests Part Number: 10491447 Product Usage: The RAPIDPoint 500 system is designed for professional use in a point-of-care or laboratory environment. This system tests blood gases, electrolytes, metabolites, total hemoglobin, and hemoglobin derivatives in arterial, venous, and capillary whole blood samples. The following parameters are tested: pH, pC02, p02, Na+, K+, Ca++, Cl-, glucose, lactate, tHb, F02Hb, FCHb, FMetHb, FHHb, nBili
Reason
RAPIDPoint 500 measurement cartridge serial numbers 2517102517 through 2519000012, negative sodium bias on both QC and patient results
Identifiers
| code_info | Serial Numbers: 2517102517 through 2519000012. Cartridges within this serial number range that have a green dot on the…Serial Numbers: 2517102517 through 2519000012. Cartridges within this serial number range that have a green dot on the box and/or the cartridge are not affected |
|---|
Status history
No status changes recorded since RecallRadar first saw this recall on 2026-09-13 11:53 UTC. Current status: terminated.
Source
Official record: https://api.fda.gov/device/enforcement.json?search=recall_number:%22Z-2815-2015%22
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