Siemens N/T Protein Control SL Recalled for Inaccurate Ceruloplasmin Values
CSL Behring GmbH is recalling Siemens N/T Protein Control SL products because they were incorrectly value-assigned, leading to biased 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 is a diagnostic inaccuracy (negative bias) rather than a direct physical injury or contamination, fitting the criteria for a moderate severity recall involving potential misdiagnosis without reported harm.
Plain-English summary
CSL Behring GmbH is recalling specific lots of Siemens N/T Protein Control SL used on the BN II and BN ProSpec Systems. The affected products include N/T Protein Control SL/L, SL/M, and SL/H, identified by specific reference and product codes.
The recall was initiated because the affected standards and controls were incorrectly value-assigned for Ceruloplasmin. This error resulted in a negative bias of approximately -20% for results obtained when calibrating Ceruloplasmin with these lots. The N Antiserum to Human Ceruloplasmin (REF OUIE) is not affected and works as intended.
The products were distributed worldwide, including in the United States and numerous other countries. Users should check their inventory against the specific lot numbers and expiration dates listed in the recall notice and stop using the affected lots.
The recalled product
- Product
- SIEMENS N/T Protein Control SL for use on the BN II, BN ProSpec Systems: N/T Protein Control SL/L: REF/Product Code OQIN19, SMN 10446079 (Low); N/T Protein Control SL/M, REF/Product Code OQIO19, SMN 10446085 (Mid); N/T Protein Control SL/H, REF/Product Code OQIP19, SMN 10446089
- Manufacturer
- CSL Behring GmbH
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 (15)
- SMN 10446079: Lot (UDI): 084647A (00842768016127084647A20170913)
- 084647C (00842768016127084647C20170913) exp. date 2017-09-13
- 084648(0084276801612708464820180430)
- 084648C (00842768016127084648C20180430)
- 084648H (00842768016127084648H20180430)
- 084750 (03 0084276801613408475020180203)
- 084750B (00842768016134084750B20180203)
- 084847B (00842768016110084847B20170613) exp. date 2017-06-13
- 084848A (00842768016110084848A20171217)
- 084848D (00842768016110084848D20171217)
- 084848E (00842768016110084848E20171217)
- 084848H (00842768016110084848H20171217)
- 084848L (00842768016110084848L20171217) exp. date 2017-12-17
- 084849 (0084276801611008484920180704)
- 084849C (00842768016110084849C20180704)
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.
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