ADVIA Centaur Systems Progesterone Kit — Class II medical device recall Z-1229-2015
Terminated recall by Siemens Healthcare Diagnostics, Inc, reported 2015-03-11, distributed nationwide. ADVIA Centaur Systems Progesterone Kit Lots Ending in 268 have a high bias on results greater than 30 ng/mL (9
| Recall number | Z-1229-2015 |
|---|---|
| Product type | Medical device |
| Classification | Class II |
| Status | Terminated |
| Voluntary or mandated | Voluntary |
| Recalling firm | Siemens Healthcare Diagnostics, Inc, East Walpole, MA, United States |
| Recall initiated | 2015-01-27 |
| Classified | 2015-03-02 |
| Reported by FDA | 2015-03-11 |
| Terminated | 2016-03-31 |
| Distributed | Nationwide (US) |
| Countries outside the US | AE, AT, BE, BG, BH, BR, CA, CH, CL, CO, CY, CZ, DE, DK, EE, EG, ES, FR, GR, HR, HU, IE, IN, IQ, IR, IT, JO, JP, LB, LT, LU, LV, MA, MX, NL, NO, OM, PE, PK, PL, PT, QA, RO, RS, SE, SK, TR, TW |
| Quantity | 9,778 kits |
| Lot numbers | 42564268, 42621268, 43834268 |
| Model numbers | 02382928 |
| Expiration dates | 2015-05-22 |
Product
ADVIA Centaur Systems Progesterone Kit, (1 -pack) In Vitro Diagnostic; Catalog number: 02382928; SMN: 10310305.
Reason for recall
ADVIA Centaur Systems Progesterone Kit Lots Ending in 268 have a high bias on results greater than 30 ng/mL (95.4 nmol/L)
Machine access
This record, with every extracted code, the verbatim FDA record and provenance, is available from the recall API: GET https://api.data.aroqon.com/v1/recalls/Z-1229-2015. Look up any UPC, UDI, NDC or lot with /v1/recalls/lookup?code=…. API docs · free and paid keys.
Source: U.S. Food and Drug Administration enforcement report via openFDA (CC0). Structured by Data Foundry (recall-structuring@2); last changed 2026-09-26. Not affiliated with or endorsed by FDA. Not medical or legal advice.