Siemens Chemistry Calibrator — Class II medical device recall Z-0365-2014
Terminated recall by Siemens Healthcare Diagnostics, reported 2013-11-27, distributed nationwide. Siemens Healthcare Diagnostics is conducting a field correction for Siemens Chemistry Calibrator Lots 090445B
| Recall number | Z-0365-2014 |
|---|---|
| Product type | Medical device |
| Classification | Class II |
| Status | Terminated |
| Voluntary or mandated | Voluntary |
| Recalling firm | Siemens Healthcare Diagnostics, Tarrytown, NY, United States |
| Recall initiated | 2013-09-24 |
| Classified | 2013-11-19 |
| Reported by FDA | 2013-11-27 |
| Terminated | 2018-05-17 |
| Distributed | Nationwide (US) |
| Countries outside the US | AE, AR, AT, BE, BG, CA, CH, CL, CN, CO, CZ, DE, DK, EE, EG, ES, FR, GB, GR, GT, HR, ID, IL, IT, KR, LT, LU, LV, MX, NL, NO, PE, PL, PT, RS, SE, SG, SI, SK, TH, TN, TR, TW, UY, VN |
| Reason classes | potency |
| Lot numbers | 090445B |
| Model numbers | 09784096, T03-1291-62 |
| Expiration dates | 2014-07, 2014-10 |
Product
Siemens Chemistry Calibrator (CAL) used with the ADVIA Chemistry Direct Bilirubin_2 Reagent, Siemens Material Number (SMN) 10312279, REF 09784096, Part Number T03-1291-62; IVD Product usage: Usage: DBIL_2: For in vitro diagnostic use in the quantitative determination of direct bilirubin in human serum and plasma on the ADVIA Chemistry systems. Such measurements are useful in the screening of liver function disorders or in the diagnosis of jaundice.
Reason for recall
Siemens Healthcare Diagnostics is conducting a field correction for Siemens Chemistry Calibrator Lots 090445B and 090445C on the ADVIA 1200, 1650, 1800, and 2400 Chemistry Systems. The System Specific Values (SSVs) for the Direct Bilirubin Assay (DBIL_2) have been reassigned for these lots. Siemens has determined that the DBIL_2 SSVs currently assigned to these lots may cause an average shift of
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-0365-2014. 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.