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Class 2 Device Recall Siemens Calibrator E |
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Date Initiated by Firm |
September 26, 2014 |
Date Posted |
December 16, 2014 |
Recall Status1 |
Terminated 3 on January 29, 2016 |
Recall Number |
Z-0164-2015 |
Recall Event ID |
69430 |
510(K)Number |
K932955
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Product Classification |
Calibrator, multi-analyte mixture - Product Code JIX
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Product |
Siemens Calibrator E; SMN 10309079 (2 pack), SMN 10321075 (6 pack), SMN 10335532 (6 pack Ref) |
Code Information |
26284A38, 26900A38, 27991A38, 28192A38, 29571A38, 31162A38, 32488A38, 35243AB39, 35295AB39, 36091AB39, 39464AB39, 40245AB39, 41317AB39, 26285A38, 27348A38, 29169A38, 30710A38, 31261A38, 32687A38, 35259AB39, 35359AB39, 36289AB39, 39031AB39, 41124AB39, 27236A38, 35051A38, 35839AB39, 40141AB39, 41702AB39 |
Recalling Firm/ Manufacturer |
Siemens Healthcare Diagnostics, Inc 333 Coney St East Walpole MA 02032-1516
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For Additional Information Contact |
877-229-3711
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Manufacturer Reason for Recall |
Positive bias for Calibrator E lot kits ending in 38 and 39 with the ADVIA Centaur Systems Cortisol and Progesterone assays compared to the respective master curves.
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FDA Determined Cause 2 |
Device Design |
Action |
An Urgent Medical Device Correction (UMDC) was sent to all affected Siemens Healthcare Diagnostics customers in the United States on September 26, 2014. An Urgent Field Safety Notice (UFSN) was sent out for distribution to all customers outside the United States on September 26, 2014. These notices inform the customer of the positive bias with ADVIA Centaur Systems Cortisol and Progesterone when calibrated with Calibrator E kit lots ending in 38 and 39.Customers may continue use of the affected lots as the clinical utility of the assay is not impacted. The communications also provide information on the performance of the assays when they use Calibrator E kit lots ending in 40. The notices should be reviewed with the facility's laboratory or Medical director.
All affected domestic customers were sent a hard copy of the Urgent Medical Device Correction via Federal Express. Fax-back forms will be used to confirm that the customers received the UMDC. For those customers that do not return a fax-back form, a Siemens representative will follow up with those customers to ensure they received the Urgent Medical Device Correction and completed the required actions.
All affected customers outside the US will be provided a copy of the Urgent Field Safety Notice via hard copy, e-mail, and/or fax as determined by each country's local regulations and procedures. Each customer will be required to return a completed confirmation fax-back to Siemens. For those customers that do not return a fax-back form, a Siemens representative will follow up with those customers to ensure they received the Urgent Field Safety Notice and completed the required actions. |
Quantity in Commerce |
Total = 19,352 (13,881 - 2 pack, 4878 - 6 pack, 593 - 6 pack REF) |
Distribution |
Nationwide including Puerto Rico. Worldwide: Afghanistan, Armenia, Austria, Bahrain, Belgium, Bulgaria, Burkina Faso, Canary Islands, Croatia, Cyprus, Czech Republic, Denmark, Estonia, Finland, France, Georgia, Germany, Great Britain, Greece, Hungary, Iran, Iraq, Ireland, Italy, Jordan, Kazakhstan, Latvia, Lebanon, Libya, Lithuania, Luxembourg, Macedonia, Malta, Morocco, Netherlands, Norway, Oman, Pakistan, Poland, Portugal, Qatar, Romania, Russian Fed., Saudi Arabia, Serbia, Slovakia, Spain, Sweden, Switzerland, Turkey, Unit.Arab Emir., Vatican, Yemen, AR, AU, BD, BR, CA , CH, CL, CN, CO, DO, EC, EG, GT, HK, ID, IE, IL, IN, JP, KR, LY, MM, MX, MY, NI, NP, NZ, PE, PH, PY, SA, SG, SV, TH, TW, UY, VN, ZA |
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 = JIX and Original Applicant = CIBA CORNING DIAGNOSTICS CORP.
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