• Decrease font size
  • Return font size to normal
  • Increase font size
U.S. Department of Health and Human Services

Class 3 Device Recall ADVIA Centaur Calibrator A

  • Print
  • Share
  • E-mail
-
Super Search Devices@FDA
510(k) | Registration & Listing | Adverse Events | Recalls | PMA | Classification | Standards | Inspections
CFR Title 21 | Radiation-Emitting Products | X-Ray Assembler | Medsun Reports | CLIA | TPLC
 


New Search Back to Search Results
 Class 3 Recall
ADVIA Centaur Calibrator A
see related information
Date Posted August 14, 2013
Recall Status1 Open
Recall Number Z-1970-2013
Recall Event ID 65626
Premarket Notification
510(K) Number
K961510 
Product Classification Calibrator, Primary - Product Code JIS
Product ADVIA Centaur Calibrator A. Cat. #04800735, SMN 10285904 (6 pack); Cat. # 04800840, SMN 10285905 (6 pack - REF). For calibrating the following assays using the ADVIA Centaur or ACS:180 systems: FT3, T3, T4, Tup, FT4, THEO2.
Code Information REF 10285904 (6 pack): 89983A77 16 Jul 2013, 90669A77 16 Jul 2013; REF 10285905 (6 pack - REF); 90705A77 16 Jul 2013
Recalling Firm/
Manufacturer
Siemens Healthcare Diagnostics, Inc
333 Coney St
East Walpole, Massachusetts 02032-1516
Manufacturer Reason
for Recall
Calibrator A lot CA77 is under-recovering to the assigned target for the ADVIA Centaur Total T4 Assay.
FDA Determined
Cause 2
COMPONENT CONTROLS (GMP - GOOD MANUFACTURING PRACTICE): Nonconforming Material/Component
Action An Urgent Medical Device Correction (UDMC) was sent to all affected Siemens Healthcare Diagnostic customers in the United States on June 28, 2013 via FedEx. An Urgent Field Safety Notice (UFSN) was sent out for distribution to all customers outside the United States on June 27, 2013. FedEx Return Receipts will be used to confirm that the customers received the UMDC. If confirmation of receipt by any customer cannot be verified through a return receipt, a Siemens Technical Solutions Center Representative will contact those customers by telephone to ensure that they received the Urgent Medical Device Correction and completed the required actions. These notices inform the customer that they should discontinue the use of Calibrator A, lots ending in 77, for use with the ADVIA Centaur Systems T4 assay. Customers are informed that they may continue to use Calibrator A lot CA77 with the other assays FT3, FT4, Total T3, T-Uptake. For questions or additional information contact your local Technical Support Provider or Distributor.
Quantity in Commerce 265 Cal A 6 packs (US and OUS)
Distribution Worldwide Distribution-Nationwide including PR and the states of AL, AR, AZ, CA, CO, CT, FL, GA, IA, IL, IN, KS, KY, LA, MA, MD, MI, MN, MO, NC, NJ, NV, NY, OH, PA, TN, TX, VA, VT, and WV and the countries of Slovakia, Germany, Turkey, TW, HK, CH, TH, BR, CN, SG, and ZA.
Total Product Life Cycle TPLC Device Report

 
1 For details about termination of a recall see Code of Federal Regulations (CFR) Title 21 §7.55
2 Per FDA policy, recall cause determinations are subject to modification up to the point of termination of the recall.
510(K) Database 510(K)s with Product Code = JIS and Original Applicant = CIBA CORNING DIAGNOSTICS CORP.
-
-