Siemens N/T Protein Control SL Recall: Results May Be 20% Lower for Ceruloplasmin Testing
Siemens Healthcare recalls N/T Protein Control SL for Ceruloplasmin testing due to potential 20% lower results. Affected lots have incorrect value assignments. No remedy provided in recall notice.
Lower-risk 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.
Contact the company
What happened, in plain English
Siemens Healthcare is recalling N/T Protein Control SL reagents for Ceruloplasmin testing because they may produce results that are 20% lower than expected. This could lead to inaccurate test results if used with the BN II or BN ProSpec Systems. Read more at govinfonow.com/recall/73957-siemens-n-t-protein-control-sl-recall-results-may-be.
Source Summary by GovInfoNow · govinfonow.com/recall/73957-siemens-n-t-protein-control-sl-recall-results-may-be · Updated September 23, 2026 · FDA enforcement record: FDA #Z-0191-2018
Cite this page
“Siemens N/T Protein Control SL Recall: Results May Be 20% Lower for Ceruloplasmin Testing.” GovInfoNow, updated September 23, 2026. https://govinfonow.com/recall/73957-siemens-n-t-protein-control-sl-recall-results-may-be. Based on FDA recall #Z-0191-2018 (https://api.fda.gov/device/enforcement.json?search=recall_number:%22Z-0191-2018%22&limit=1).
Why it’s dangerous
The reagents have a negative bias of about -20% when calibrating Ceruloplasmin tests. This means results may be 20% lower than they should be, potentially leading to incorrect test outcomes. The issue is specific to the N Protein Standard SL and corresponding N/T Protein Control SL reagents.
Who’s affected
Users of Siemens BN II or BN ProSpec Systems who have the affected N/T Protein Control SL reagents (specific lot numbers) may experience inaccurate Ceruloplasmin test results. Laboratory staff and healthcare providers using these reagents are most at risk.
How to tell if you have this one
Check for the product code OQIN19 (Low), OQIO19 (Mid), or OQIP19 (High) with specific lot numbers listed in the recall notice. The affected lots have expiration dates from 2017-06-13 to 2018-07-04.
- Brand
Siemens Healthcare- Category
Medical device
All 2 products in this recall
FDA lists each product line separately under one recall event. Check your product description, lot or code numbers against each row. Every row shares the hazard and remedy on this page.
- Classification
Class II- Status
Terminated- 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,
| Recall number | Product, codes & lots |
|---|---|
| Z-0190-2018 | SIEMENS N Protein Standard SL, for use on the BN II, BN ProSpec Systems, REF/Product Code OQIM 13, Siemens Material Number (SMN)10446073; 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. |
| Z-0191-2018 | 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);; 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. |
What to do — step by step
Check Product Lot Numbers
Identify the lot numbers from the recall notice to determine if your reagent is affected.
How this recall unfolded
Recall timeline
FDA terminated this recall 2.8 years after the firm started it.
- Firm started the recall
- FDA classified it Class II
- Published in FDA’s Enforcement Report
- FDA terminated the recall
Dates from the agency record only; steps without a date are left out.
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Where this comes from
The facts (hazard, remedy, dates, manufacturer) are pulled from the official FDA recall record. The plain-language summary and step-by-step checklist are written by GovInfoNow to make the official notice easier to act on — they don’t replace it.
- Official source: FDA Recall #Z-0191-2018 (June 5, 2017) — FDA publishes no per-recall page; this is the official machine-readable enforcement record. Search FDA recalls for Z-0191-2018 to see it in context.
- Plain-language summary written by qwen3:4b on September 23, 2026, from the official record above. Not reviewed by a person — if it conflicts with the FDA notice, the notice is correct. Report an error on this page.
- GovInfoNow is an independent service and is not a government agency. We republish official FDA recall data; we don’t issue, amend or administer recalls.