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Class 2 Device Recall Advia Chemistry Systems Calibrator |
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Date Initiated by Firm |
October 07, 2016 |
Create Date |
November 16, 2016 |
Recall Status1 |
Terminated 3 on May 10, 2018 |
Recall Number |
Z-0589-2017 |
Recall Event ID |
75487 |
510(K)Number |
K050374
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Product Classification |
Multi-analyte controls, all kinds (assayed) - Product Code JJY
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Product |
Advia Chemistry Calibrator For in vitro diagnostic use in the calibration of ADVIA¿ Chemistry systems for the following methods: Albumin (ALB, ALB_c), Direct Bilirubin (DBIL_2), Total Bilirubin (TBIL_2), Calcium (CA, CA_c, CA_2, CA_2c), Cholesterol (CHOL), Creatinine (CREA, CREA_2, CRE_2c, ECRE_2), Glucose Hexakinase (GLUH), Glucose Oxidase (GLUO), Iron (IRON_2), Lithium (LITH), Magnesium (MG, MG_c), Phosphorus - inorganic (IP, IP_c), Total Protein (TP, TP_c), Triglycerides (TRIG), Urea Nitrogen (UN, UN_c), Uric Acid (UA, UA_c)
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Code Information |
Device Listing # D033650 Model# SMN# 10312279 Lot Numbers: 680726, 680726A, 680726B, 680726C, 680726D |
Recalling Firm/ Manufacturer |
Siemens Healthcare Diagnostics, Inc. 511 Benedict Ave Tarrytown NY 10591-5005
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For Additional Information Contact |
914-631-8000
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Manufacturer Reason for Recall |
Siemens has confirmed that the DBIL_2 Assigned Calibrator Values (ACV) currently assigned to the affected lots may cause, on average, a positive proportional bias of approximately 41% on patient samples compared to the reference method for Direct Bilirubin measurement.
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FDA Determined Cause 2 |
Under Investigation by firm |
Action |
Siemens issued an Urgent Medical Device Correction in the US and an Urgent Field Safety Notice Outside the US beginning on October 6, 2016. Customers were notified of the issue and instructed to use the reassigned DBIL_2 calibrator value for Chemistry Calibrator Lot Numbers 680726, 680726A, 680726B, 680726C and 680726D. Customers were also requested to complete and return the Effectiveness Check questionnaire attached to the Urgent Medical Device Correction letter within 30 days by faxing to the Customer Care Center at 312-275-7795.
For questions regarding this recall call 914-631-8000. |
Quantity in Commerce |
10,614 units |
Distribution |
Worldwide Distribution - US (Nationwide) Internationally to Canada, Mexico, Algeria, Australia, Austria, Bangladesh, Belgium, Brazil, Chile, Cyprus, Denmark, Egypt, Ecuador, Finland, France, Germany, Great Britain, Hong Kong, Hungary, Italy, Japan, Lithuania, Malaysia, Mexico, Netherlands, New Zealand, Norway, Pakistan, Paraguay, Peru, Poland, Portugal, Russian Fed. Slovakia, Slovenia, Spain, Sweden, Switzerland, Thailand, Turkey, Vatican City and Vietnam |
Total Product Life Cycle |
TPLC Device Report
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1 A record in this database is created when a firm initiates a correction or removal action. The record is updated if the FDA identifies a violation and classifies the action as a recall, and it is updated for a final time when the recall is terminated. Learn more about medical device recalls.
2 Per FDA policy, recall cause determinations are subject to modification up to the point of termination of the recall.
3 For details about termination of a recall see Code of Federal Regulations (CFR) Title 21 §7.55.
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510(K) Database |
510(K)s with Product Code = JJY and Original Applicant = BAYER HEALTHCARE, LLC
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