CSL Behring GmbH: 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 (High);

Recall number

Z-0191-2018

Recalling firm

CSL Behring GmbH

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 (High);

Status

Terminated

Initiated

2017-06-05

Posted

not on file

Terminated

2020-04-07

Reason

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.

Root cause

Nonconforming Material/Component

Action

URGENT MEDICAL DEVICE CORRECTION Letter (PP17-011.a.US, dated May 30, 2017) was sent to US consignees via FedEx on 6/5/2017. URGENT FIELD CORRECTIVE ACTION Letter was e-mailed to customers Outside the US. Customers are instructed to use the re-assigned Ceruloplasmin values for the lots indicated in the letter.

Quantity

not on file

Distribution

Worldwide including the countries of United States, Argentina, Australia, Austria, Bahrain, Bangladesh, Belgium, Bosnia-Herzegovina, Brazil, Bulgaria, Canada, Chile, China, Costa Rica, Croatia, Czech Republic, Cyprus, Denmark, Egypt, Finland, France, Germany, Greece, Great Britain, Hungary, India, Indonesia, Iraq, Ireland, Israel, Italy, japan, Kazakhstan, Kuwait, Latvia, Lebanon, Luxembourg, Macedonia, Mexico, Morocco, Netherlands, New Zealand, Norway, Poland, Portugal, Republic of Korea (S), Romania, Russian Federation, Saudi Arabia, Serbia, Singapore, Slovakia, Slovenia, Spain, Sweden, South Africa, Switzerland, Syria, Taiwan, Thailand, Trinidad-Tobago, Turkey, Turkmenistan, United Arab Emirates, Uruguay, Vatican, Venezuela,

Lot, serial or model codes

SMN 10446079: Lot (UDI): 084647A (00842768016127084647A20170913), 084647C (00842768016127084647C20170913) exp. date 2017-09-13; 084648(0084276801612708464820180430),  084648C (00842768016127084648C20180430),  084648H (00842768016127084648H20180430), exp. date 2018-04-30. --- SMN 10446085: Lot (UDI): 084749D (00842768016134084749D20170917) exp. date 2017-09-17; 084750 (03 0084276801613408475020180203),  084750B (00842768016134084750B20180203), 084750E (00842768016134084750E20180203) exp. date 2018-02-03. --- SMN 10446089: Lot (UDI) 084847A (00842768016110084847A20170613),  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), 084849D (00842768016110084849D20180704) 084849E (00842768016110084849E20180704) exp. date 2018-07-04.

510(k) numbers

["K052788"]

PMA numbers

not on file

Product code

CHN

Firm FEI

3003098680

Firm city

Marburg

Firm state

not on file

Firm country

Germany

Cite as

FDA Medical Device Recalls (openFDA) (U.S. Food and Drug Administration (openFDA)), device-recall-0001-of-0001.json.zip, sha256 b87518bfe2e8, published 2026-09-28

Copy