🔍 RecallPedia

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

Class I - Dangerous
🏥 Medical Devices Recalled: June 5, 2017 CSL Behring GmbH Other Medical Devices

What Should You Do?

  1. Check if you have this product:
    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.
  2. Do not eat it: Even if it looks and smells fine, do not consume this product.
  3. Throw it away or return it: You can return the product to the store for a full refund.
  4. Seek medical attention if needed: If you've consumed this product and feel unwell, contact your doctor immediately.
  5. Report problems: Report any issues to the FDA's Safety Reporting Portal.

⚠️ Emergency: If you experience severe symptoms after consuming this product, call 911 or Poison Control at 1-800-222-1222.

Recall Details

Company:
CSL Behring GmbH
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.
Classification:
Class I - Dangerous

Dangerous or defective products that predictably could cause serious health problems or death.

Status:
terminated

Product Information

Full 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 Codes/Lot Numbers:

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.

Official Source

Always verify recall information with the official FDA source:

View on FDA.gov

FDA Recall Number: Z-0190-2018

Related Recalls

N Latex CDT Kit

CSL Behring GmbH

Class I - Dangerous

Siemens Healthcare Diagnostics has observed a negative bias for the carbohydrate-deficient transferrin (CDT) measurement when using the affected N Latex CDT lots in comparison to the HPLC method. CDT results in absolute concentrations may be influenced by patients transferrin levels and, therefore, results are reported as ratio of CDT to total transferrin, called %CDT. As the transferrin determination with N Antiserum to Human Transferrin is not affected, the observed effect leads to calculated %CDT values that show a negative bias of approximately 15% compared to the HPLC method. This could result in a shift of weak positive patient samples into the reference range of 1.19  2.47 %CDT which was derived from a study population of healthy adults. There are no control or calibrator materials that would catch this bias.

May 31, 2018 Other Medical Devices View Details →

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);

CSL Behring GmbH

Class I - Dangerous

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.

Jun 5, 2017 Other Medical Devices View Details →