FDA Device recall Z-0610-2016
Siemens Acute Care pBNP TestPak- in vitro diagnostic test for the quantitative measurement of N-terminal pro-brain natriuretic peptide (NTp…
- FDA Device
- Class II
- terminated
- Published 2016-01-13
On 2016-01-13 the FDA classified a Class II recall of Siemens Acute Care pBNP TestPak- in vitro diagnostic test for the quantitative measurement of N-terminal pro-brain natriuretic peptide (NTp… by Siemens Healthcare Diagnostics, citing stratus CS Cartridge Barcode labels may not scan on the Stratus CS systems.
Read the official FDA Device notice
| Agency | FDA Device |
|---|---|
| Recall number | Z-0610-2016 |
| Classification | Class II |
| Status | terminated |
| Initiated | 2015-11-11 |
| Published | 2016-01-13 |
| Last updated | 2026-09-13 11:54 UTC |
| Company | Siemens Healthcare Diagnostics |
| Distribution | US |
Product
Siemens Acute Care pBNP TestPak- in vitro diagnostic test for the quantitative measurement of N-terminal pro-brain natriuretic peptide (NTproBNP) in heparinized plasma. Catalog Number: CPBNPM SMN: 10445086
Reason
Stratus CS Cartridge Barcode labels may not scan on the Stratus CS systems
Identifiers
| code_info | Lot Numbers: 215166002, 215194002, 215222002, 215271002 |
|---|
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-0610-2016%22
RecallRadar indexes public recall notices from the FDA, USDA FSIS, and CPSC. The official agency notice is the authoritative source. Always confirm details at the linked source before acting.