Severity
Moderate
ModerateClass IITerminated
FDA Devices recall · Reported December 6, 2017
SIEMENS N Protein Standard SL, for use on the BN II, BN ProSpec Systems, REF/Product Code OQIM 13, Siemens Material Number (SMN)10446073
Siemens Healthcare Diagnostics has confirmed a negative bias of approximately -20% for results obtained with N Antiserum to Human Ceruloplasmin when calibrating Ceruloplasmin with…
Compiled from official public sources by the editorial team.
Verify with FDA Devices →
Csl Behring GmbH recalled SIEMENS N Protein Standard SL, for use on the BN II, BN ProSpec Systems, REF/Product Code… - a moderate-severity action.
SIEMENS N Protein Standard SL, for use on the BN II, BN ProSpec Systems, REF/Product Code… was recalled by Csl Behring GmbH in December 6, 2017. Reason: Siemens Healthcare Diagnostics has confirmed a negative bias of approximately -20% for results obtained with …. Check the official notice for the remedy. Verify recall #Z-0190-2018 with the FDA Devices before acting.
The recall
Csl Behring GmbH issued this moderate-severity FDA Devices recall-Siemens Healthcare Diagnostics has confirmed a negative bias of approximately -20% for results obtained with ….
- Moderate
- severity level
- Class II
- classification
- December 6, 2017
- reported
Sourced from official FDA Devices enforcement records. Verify recall #Z-0190-2018 with the agency before acting. Full product description, hazard, remedy, and related recalls are below.
Recall Insight
This FDA Devices action (record #Z-0190-2018) was formally reported on December 6, 2017, with the manufacturer initiating the action on June 5, 2017. It is classified under Moderate severity (Class II), with a current status of Terminated. Csl Behring GmbH is listed as the recalling firm, operating out of Marburg, N/A. Federal records list the affected scope as N/A.
The documented reason for this recall is: 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. … Distribution data in the federal record shows the product reached: 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, D…. Distribution scope directly affects the consumer exposure window and determines whether a recall remains regional or escalates into a nationwide advisory.
Within the same product category the archive holds 6 closely related recalls - clustering in a narrow category often points to a systemic quality-control or supplier issue rather than a one-off defect. Always verify the recall number against the official agency record before acting.
Medical Devices recalls over time
Where this recall sits in its category - 40,422 medical devices recalls on record
Of 101,704 recalls in the database, 24,878 are high severity, 72,426 moderate, and 4,400 low. This recall is classified moderate severity.
Counts reflect market size and reporting activity, not inherent danger, we do not rank products by risk from raw recall volume.
Affected scope
N/A
Related Recalls
6
0 from same agency
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
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.
Recall Profile
| Attribute | Value |
|---|---|
| Agency | U.S. Food and Drug Administration |
| Severity class | Moderate (Class II) |
| Status | Terminated |
| Recall number | Z-0190-2018 |
| Date reported | December 6, 2017 |
| Date initiated | June 5, 2017 |
| Recalling firm | Csl Behring GmbH |
| Firm location | Marburg, N/A |
| Affected scope | N/A |
| 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, Finla… |
Profile values are sourced directly from the official FDA Devices enforcement record. Source: U.S. Food and Drug Administration.
What to do with this recall
Match your product against the recall record, then act on the agency remedy.
- Check the recall number (Z-0190-2018) and product description against the item you own. Search the archive
- Confirm the current status with FDA Devices before acting, recall details can be updated.
- Follow the documented remedy (refund, replacement, repair, or disposal) rather than general advice. What to do next
This page summarizes the official FDA Devices record for research and awareness; it is not legal, medical, or safety advice. Verify with the issuing agency before acting.
Frequently Asked Questions
What product was recalled? ▼
SIEMENS N Protein Standard SL, for use on the BN II, BN ProSpec Systems, REF/Product Code OQIM 13, Siemens Material Number (SMN)10446073. Recalled by Csl Behring GmbH. Units affected: N/A.
Why was this product recalled? ▼
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.
Which agency issued this recall? ▼
This recall was issued by the FDA Devices on December 6, 2017. Severity: Moderate. Recall number: Z-0190-2018.
Where was the recalled product distributed? ▼
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,.
How do I check if my product is affected by a recall? ▼
Check the product description and recall number (Z-0190-2018) against your product. Visit the official FDA Devices website for the most current information. You can also use our Recall Checker tool to search by product name or brand.
Should I stop using a recalled medication or medical device? ▼
Do not stop using a recalled medication or device without consulting your healthcare provider first, as abruptly discontinuing treatment could pose its own health risks. Your doctor can advise on alternatives or whether the recall applies to your specific product lot. Check the recall number and lot information against your product packaging.
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Every figure on PlainRecalls is rendered directly from official FDA, CPSC and NHTSA recall records, no number is typed in by an editor. This recall: FDA Devices, reported December 6, 2017. Severity classes follow each agency's own taxonomy (FDA Class I/II/III; CPSC and NHTSA by hazard type), and related-recall context is computed across the full archive. See our editorial standards & corrections policy, the methodology behind these numbers, or report a data error. Data current as of July 2026.