FDA Device recall Z-1229-2015
ADVIA Centaur Systems Progesterone Kit, (1 -pack) In Vitro Diagnostic
- FDA Device
- Class II
- terminated
- Published 2015-03-11
On 2015-03-11 the FDA classified a Class II recall of ADVIA Centaur Systems Progesterone Kit, (1 -pack) In Vitro Diagnostic by Siemens Healthcare Diagnostics, citing ADVIA Centaur Systems Progesterone Kit Lots Ending in 268 have a high bias on results greater than 30 ng/mL (95.4 nmol/L).
Read the official FDA Device notice
| Agency | FDA Device |
|---|---|
| Recall number | Z-1229-2015 |
| Classification | Class II |
| Status | terminated |
| Initiated | 2015-01-27 |
| Published | 2015-03-11 |
| Last updated | 2026-09-13 11:53 UTC |
| Company | Siemens Healthcare Diagnostics |
| Distribution | US |
Product
ADVIA Centaur Systems Progesterone Kit, (1 -pack) In Vitro Diagnostic; Catalog number: 02382928; SMN: 10310305.
Reason
ADVIA Centaur Systems Progesterone Kit Lots Ending in 268 have a high bias on results greater than 30 ng/mL (95.4 nmol/L)
Identifiers
| code_info | Lot Numbers: 42564268 42621268 43834268 Exp. Date: May 22, 2015 |
|---|
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-1229-2015%22
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