SIEMENS N Protein Standard SL — Class II medical device recall Z-0190-2018
Terminated recall by CSL Behring GmbH, reported 2017-12-06. Siemens Healthcare Diagnostics has confirmed a negative bias of approximately -20% for results obtained with N
| Recall number | Z-0190-2018 |
|---|---|
| Product type | Medical device |
| Classification | Class II |
| Status | Terminated |
| Voluntary or mandated | Voluntary |
| Recalling firm | CSL Behring GmbH, Marburg, N/A, Germany |
| Recall initiated | 2017-06-05 |
| Classified | 2017-11-30 |
| Reported by FDA | 2017-12-06 |
| Terminated | 2020-04-07 |
| Countries outside the US | AE, AR, AT, AU, BD, BE, BG, BH, BR, CA, CH, CL, CN, CR, CY, CZ, DE, DK, EG, ES, FI, FR, GB, GR, HR, HU, ID, IE, IL, IN, IQ, IT, JP, KR, KW, LB, LU, LV, MA, MX, NL, NO, NZ, PL, PT, RO, RS, SA, SE, SG, SI, SK, TH, TR, TT, TW, UY, VE, ZA |
| Lot numbers | 083611A, 083611B, 083611C, 083611D, 083612, 083612A, 083612B, 083614A, 083614B, 083614C, 083615, 083615A, 083615B, 083615C, 083616B, 083616C, 083616D |
| Expiration dates | 2017-07-11, 2017-10-14, 2018-01-27, 2018-04-11, 2018-07-30 |
Product
SIEMENS N Protein Standard SL, for use on the BN II, BN ProSpec Systems, REF/Product Code OQIM 13, Siemens Material Number (SMN)10446073
Reason for recall
Siemens Healthcare Diagnostics has confirmed a negative bias of approximately -20% for results obtained with N Antiserum to Human Ceruloplasmin when calibrating Ceruloplasmin with various lots of N Protein Standard SL. N/T Protein Controls SL for Ceruloplasmin are similarly biased. --- The affected standards and controls for the affected lots were incorrectly value assigned, which led to a lower result compared to correctly assigned standards. Note: N Antiserum to Human Ceruloplasmin (REF OUIE) works as intended. --- Siemens investigation indicated that N Protein Standard SL and corresponding N/T Protein Control SL (Levels Low, Mid and High) are inaccurately assigned for Ceruloplasmin.
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-0190-2018. 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.