Siemens ADVIA Centaur Systems Calibrator A Kits — Class II medical device recall Z-1255-2017
Terminated recall by Siemens Healthcare Diagnostics, Inc, reported 2017-03-08, distributed nationwide. Siemens Healthcare Diagnostics has confirmed a negative bias for ADVIA Centaur FT4 when used with Calibrator A
| Recall number | Z-1255-2017 |
|---|---|
| Product type | Medical device |
| Classification | Class II |
| Status | Terminated |
| Recalling firm | Siemens Healthcare Diagnostics, Inc, East Walpole, MA, United States |
| Recall initiated | 2017-01-10 |
| Classified | 2017-02-25 |
| Reported by FDA | 2017-03-08 |
| Terminated | 2019-07-16 |
| Distributed | Nationwide (US) |
| Countries outside the US | AE, AF, AR, AT, AU, BD, BE, BG, BH, BR, CA, CH, CL, CN, CO, CY, CZ, DE, DK, DO, EC, EE, EG, ES, FI, FR, GB, GR, GT, HK, HR, HU, ID, IE, IL, IN, IQ, IT, JO, JP, KR, LK, LT, LU, LV, MT, MX, MY, NI, NL, NO, NP, OM, PE, PH, PK, PL, PT, PY, QA, RO, RS, SA, SE, SG, SI, SK, TH, TN, TR, TW, UY, VN, ZA |
| Quantity | 1,937 kits |
| Reason classes | potency |
| Lot numbers | 07996A90, 2017/07/24, 21172A90, 27221A90, 44366A90, 63785A90 |
| Model numbers | 04800646, 04800735, 04800840, 10285903, 10285904, 10285905 |
Product
Siemens ADVIA Centaur Systems Calibrator A Kits, Cat No. 04800646, SMN 10285903 (2 pack)Cat No. 04800735, SMN 10285904 (6 pack) Cat No. 04800840, SMN 10285905 (6 pack - REF)
Reason for recall
Siemens Healthcare Diagnostics has confirmed a negative bias for ADVIA Centaur FT4 when used with Calibrator A kit lots ending in 90 on the ADVIA Centaur, ADVIA Centaur XP and ADVIA Centaur XPT Systems. In addition, Siemens Healthcare Diagnostics confirmed the potential for calibration failures due to above limit calibrator RLU %CVs when using Calibrator A kit lots ending in 90 with the FT4 assay. The performance of the FT4 assay when used with Calibrator A kit lots ending in 90 on the ADVIA Centaur CP System is not affected. Customers may continue to use Calibrator A kit lots ending in 90 for the ADVIA Centaur Systems FT3, T3, T4 and TUp assays.
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-1255-2017. 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.