Z-0191-2018Class II

SIEMENS N/T Protein Control SL for use on the BN II, BN ProSpec Systems: N/T Protein Control SL/L...

Name: Z-0191-2018 SIEMENS N/T Protein Control SL for use on the BN II, BN ProSpec Systems: N/T Protein Control SL/L...
Creator: CSL Behring GmbH
Published: 2017-06-05
License: https://open.fda.gov/license/

CSL Behring LLC / initiated 2017-06-05 / Terminated / root cause: manufacturing process

FDA source

CSL Behring GmbH began a recall of 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... on 2017-06-05. FDA classified it as Class II and gives the reason as "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...". As of 2026-09-10, the recall status on record is Terminated, and MDM tags the root cause as manufacturing process.

Recall record

Recall number: Z-0191-2018
Classification: Class II
Status: Terminated
Initiated: 2017-06-05
Posted: 2017-11-30
Terminated: 2020-04-07
Recalling firm: CSL Behring LLC
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);
Product code: CHN Immunochemical, Ceruloplasmin
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.
Root cause tag: manufacturing process
FDA 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.
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,
Product codes and lots: 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.

Enforcement reports

One row per recalled product line

FDA enforcement reports joined to recall event Z-0191-2018
Recall number	Class	Status	Voluntary or mandated	Report date	Classified
Z-0190-2018	Class II	Terminated	Voluntary: Firm initiated	2017-12-06	2017-11-30
Z-0191-2018	Class II	Terminated	Voluntary: Firm initiated	2017-12-06	2017-11-30

Product code CHN

K052788Class IIN Latex Hcy, N Protein Standard Sl, N/t Protein Control L/m/hDade Behring, Inc. / cleared 2006-03-29

MDM coverage of this record lists here, newest first.

About this record

Sourced from the FDA device recall database and the FDA enforcement reports, both ingested from openFDA. The recall record supplies the product, the reason and the product code; the enforcement report supplies the classification. The two datasets are exported by FDA on different days, and the date above is the older of the two, so nothing on this page is newer than it says.

MDM adds the root cause tag, derived from FDA’s own root cause text, and the cross-links to the product code, the clearances named on the record and MDM coverage. Where a recall has not been joined to an enforcement report, no classification is shown.

Data as of 2026-09-30, the FDA export date for this dataset. Page last changed 2026-09-05. View this recall on fda.gov (opens on fda.gov)