FDA Device recall Z-2913-2016
Siemens RAPIDPoint 405 Measurement Cartridge Siemens SMN numbers: 10844812, 1028322, 10313971 , 10310469
- FDA Device
- Class III
- terminated
- Published 2016-10-12
On 2016-10-12 the FDA classified a Class III recall of Siemens RAPIDPoint 405 Measurement Cartridge Siemens SMN numbers: 10844812, 1028322, 10313971 , 10310469 by Siemens Healthcare Diagnostics, citing error in the value assignment for the Chloride calibrators in the RAPIDPoint 400 and RAPIDPoint 405 Measurement Cartridge.
Read the official FDA Device notice
| Agency | FDA Device |
|---|---|
| Recall number | Z-2913-2016 |
| Classification | Class III |
| Status | terminated |
| Initiated | 2016-09-02 |
| Published | 2016-10-12 |
| Last updated | 2026-09-13 11:54 UTC |
| Company | Siemens Healthcare Diagnostics |
| Distribution | US |
Product
Siemens RAPIDPoint 405 Measurement Cartridge Siemens SMN numbers: 10844812, 1028322, 10313971 , 10310469
Reason
Error in the value assignment for the Chloride calibrators in the RAPIDPoint 400 and RAPIDPoint 405 Measurement Cartridge
Identifiers
| code_info | Serial Numbers:2610900214 through 2621001325. Expiry Dates: Sept 13, 2016 through Dec. 6, 2016 |
|---|
Status history
No status changes recorded since RecallRadar first saw this recall on 2026-09-13 11:54 UTC. Current status: terminated.
Source
Official record: https://api.fda.gov/device/enforcement.json?search=recall_number:%22Z-2913-2016%22
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