SIEMENS N/T Protein Control SL for use on the BN II recall
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);
Why was SIEMENS N/T Protein Control SL for use on the BN II 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.
What should I do if I have this product?
Review the official FDA enforcement record for current instructions.
What to do with a recalled product: refunds, receipts, safe disposal and how to report a problem.
Is my product affected?
Compare the item in your hand with every identifier below from the official FDA record. Only products that match the listed product and lot, UPC or model codes are part of this recall.
Which lot codes, UPCs or models are affected?
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.
- 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);
- Recalling firm
- CSL Behring GmbH
- Quantity
- 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, 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 date
- December 6, 2017
- Classification
- Class II
- Status
- Terminated
- Agency
- FDA (device)