Moderate FDA (Devices)·Z-0190-2018·Announced 2017-12-06

Siemens N Protein Standard SL Recalled for Inaccurate Ceruloplasmin Calibration

CSL Behring GmbH is recalling Siemens N Protein Standard SL and N/T Protein Controls SL due to incorrect value assignments that cause negative bias in Ceruloplasmin test results.

What this means for you

Minor labeling or packaging issue, or a voluntary precautionary recall. Risk of harm is low but real — follow the manufacturer's instructions.

Our severity reasoning: The recall is classified as FDA Class II, but the hazard involves inaccurate test results (negative bias) rather than direct physical injury or contamination, fitting the criteria for moderate severity involving potential diagnostic errors without reported harm.

Plain-English summary

CSL Behring GmbH is recalling specific lots of SIEMENS N Protein Standard SL and N/T Protein Controls SL (Levels Low, Mid, and High) used for Ceruloplasmin testing on BN II and BN ProSpec Systems. The recall is due to incorrect value assignments in the standards and controls, which resulted in a negative bias of approximately -20% for Ceruloplasmin results. This means the test results were lower than they should have been when using the affected lots.

The affected products were distributed worldwide, including in the United States, Canada, and numerous countries across Europe, Asia, and the Americas. The recall covers specific lot numbers with expiration dates ranging from July 2017 to July 2018. Siemens Healthcare Diagnostics confirmed that the N Antiserum to Human Ceruloplasmin (REF OUIE) works as intended and is not affected by this issue.

Healthcare facilities and laboratories should stop using the affected lots of N Protein Standard SL and N/T Protein Controls SL for Ceruloplasmin calibration. Users should contact CSL Behring GmbH or Siemens Healthcare Diagnostics for instructions on how to return the affected products and obtain replacements.

The recalled product

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
Manufacturer: CSL Behring GmbH
Category: Medical Device — Laboratory Reagents
Hazard: inaccurate-results
mis-labeling

Is your product affected?

Check your packaging against the codes below. If any of them match, the product is part of this recall.

Lot numbers (20)

Lot Numbers(UDI): 083611A (00842768007590083611A20170711)
083611B (00842768007590083611B20170711)
083611C (00842768007590083611C20170711)
083611D (00842768007590083611D20170711)
exp. date 2017-07-11
083612 (0084276800759008361220171014)
083612A (00842768007590083612A20171014)
083612B (00842768007590083612B20171014)
exp. date 2017-10-14
083614A (00842768007590083614A20180127)
083614B (00842768007590083614B20180127)
083614C (00842768007590083614C20180127)
exp. date 2018-01-27
083615 (0084276800759008361520180411)
083615A (00842768007590083615A20180411)
083615B (00842768007590083615B20180411)
083615C (00842768007590083615C20180411)
exp. date 2018-04-11
083616B (00842768007590083616B20180730)
083616C (00842768007590083616C20180730)

Distribution

Distribution scope not specified by the agency.

Part of a larger recall action

This product is one of 2 recalled by CSL Behring GmbH under a single FDA (Devices) recall action. The agency files each product separately, so the size of the action is not visible from this page alone.

See all 2 products in this recall →

Same manufacturer · CSL Behring GmbH

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Same hazard · inaccurate results