Reported Dec 6, 2017 · Terminated
SIEMENS N Protein Standard SL, for use on the BN II, BN ProSpec Systems, REF/Product Code OQIM 13, Siemens Material…
CSL Behring GmbH
Moderate riskThis product could cause temporary or reversible health problems — stop using it.What you should do
Stop using the affected lot and contact the recalling firm for the return or refund process. Check the FDA enforcement report for lot-level detail.
Firm contact: CSL Behring GmbH · Emil-von-Behring-Str. 76 · Marburg, N/A · N/A
Is this the product you have?
- SIEMENS N Protein Standard SL, for use on the BN II, BN ProSpec Systems, REF/Product Code OQIM 13, Siemens Material Number (SMN)10446073
- Lot codes and dates
- Lot Numbers(UDI)
083611A (00842768007590083611A20170711)083611B (00842768007590083611B20170711)083611C (00842768007590083611C20170711)083611D (00842768007590083611D20170711)exp. date 2017-07-11083612 (0084276800759008361220171014)083612A (00842768007590083612A20171014)083612B (00842768007590083612B20171014)exp. date 2017-10-14083614A (00842768007590083614A20180127)083614B (00842768007590083614B20180127)083614C (00842768007590083614C20180127)exp. date 2018-01-27083615 (0084276800759008361520180411)083615A (00842768007590083615A20180411)083615B (00842768007590083615B20180411)083615C (00842768007590083615C20180411)exp. date 2018-04-11083616B (00842768007590083616B20180730)083616C (00842768007590083616C20180730)083616D (00842768007590083616D20180730)exp. date 2018-07-30
- Lot Numbers(UDI)
- Amount recalled
- N/A
This recall covers 2 products
The agency filed one notice per product. You are reading one of them; the other one is below.
Why it was recalled
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.
This product could cause temporary or reversible health problems — stop using it.
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The guide adds the identifying codes laid out for scanning, symptoms to watch for, a timeline, and news coverage of this recall.
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