CSL Behring GmbH: Medical Device Recall in 2017 - (Recall #: Z-0190-2018)

Updated on March 25, 2026.

See the recall detail below. You can also see other recalls from the same firm in 2017.

Data Source: FDA.

Product Description:

SIEMENS N Protein Standard SL, for use on the BN II, BN ProSpec Systems, REF/Product Code OQIM 13, Siemens Material Number (SMN)10446073

Product Classification:

Class II

Date Initiated: June 5, 2017

Date Posted: December 6, 2017

Recall Number: Z-0190-2018

Event ID: 77515

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.

Status: Terminated

Product Quantity: N/A

Code Information:

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), 083616D (00842768007590083616D20180730), exp. date 2018-07-30.

Distribution Pattern:

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,

Voluntary or Mandated:

Voluntary: Firm initiated