FDA Device recall Z-0615-2016
Siemens Acute Care BHCG TestPak-an in vitro diagnostic product intended to be used for calibration of the Stratus¿ CS Acute Care hCG method…
- FDA Device
- Class II
- terminated
- Published 2016-01-13
On 2016-01-13 the FDA classified a Class II recall of Siemens Acute Care BHCG TestPak-an in vitro diagnostic product intended to be used for calibration of the Stratus¿ CS Acute Care hCG method… 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-0615-2016 |
| 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 BHCG TestPak-an in vitro diagnostic product intended to be used for calibration of the Stratus¿ CS Acute Care hCG method Catalog Number: CBHCG SMN:10445060
Reason
Stratus CS Cartridge Barcode labels may not scan on the Stratus CS systems
Identifiers
| code_info | Lot Numbers: 445146002, 445201002, 445243002 |
|---|
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-0615-2016%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.