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U.S. Department of Health and Human Services

Class 2 Device Recall ARCHITECT Intact PTH Assay

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 Class 2 Recall
ARCHITECT Intact PTH Assay
see related information
Date Posted May 29, 2014
Recall Status1 Open
Recall Number Z-1670-2014
Recall Event ID 67527
Premarket Notification
510(K) Number
K063232 
Product Classification Radioimmunoassay, Parathyroid Hormone - Product Code CEW
Product ARCHITECT Intact PTH Reagent Kit (8K25) consists of: 1 Bottle (6.6 mL) Anti-PTH (goat, polyclonal) coated microparticles in TRIS buffer with a preservative of sodium azide; 1 Bottle (5.9 mL) Anti-PTH (goat, polyclonal) acridinium-labeled conjugate in MES buffer with protein (bovine, goat) stabilizer with a preservative of sodium azide; and, 1 Bottle (10.0 mL) Intact PTH Assay Diluent containing phosphate buffer with protein (bovine, goat) stabilizer with a preservative of sodium azide. Product Usage: The ARCHITECT Intact PTH assay is an in vitro chemiluminescent microparticle immunoassay (CMIA) for the quantitative determination of intact parathyroid hormone (PTH) in human serum and plasma on the ARCHITECT i System.
Code Information 1) List Number 8K25-20; Lot Numbers and Expiration Dates: Lot 00913F000, Expires 23 NOV 2014; Lot 01313C000, Expires 21 AUG 2014; Lot 01512K000, Expires 25 APR 2014; Lot 01712H000, Expires 23 FEB 2014; Lot 01813I000, Expires 13 MAR 2015; Lot 02213K000, Expires 08 MAY 2015; Lot 01312G000, Expires 13 JAN 2014; Lot 00512H000, Expires 13 JAN 2014. 2) List Number: 8K25-25; Lot Numbers and Expiration Dates: Lot 00112K000, Expires 25 APR 2014; Lot 01113C000, Expires 21 AUG 2014; Lot 01313G000, Expires 05 JAN 2015; Lot 01612H000, Expires 23 FEB 2014; Lot 01913I000, Expires 02 FEB 2015; Lot 02213D000, Expires 05 OCT 2014; Lot 00113K000, Expires 11 APR 2015; Lot 01212G000, Expires13 JAN 2014; Lot 00412H000, Expires 13 JAN 2014. 3) List Number: 8K25-27; Lot Numbers and Expiration Dates: Lot 00212K000, Expires 25 APR 2014; Lot 01213C000, Expires 21 AUG 2014; Lot 01413G000, Expires 05 JAN 2015; Lot 01812H000, Expires 23 FEB 2014; Lot 02013I000, Expires 02 FEB 2015; Lot 02313D000, Expires 05 OCT 2014; Lot 00213K000, Expires 11 APR 2015; Lot 01412G000, Expires 13 JAN 2014; Lot 00612H000, Expires 13 JAN 2014.
Recalling Firm/
Manufacturer
Abbott Laboratories
100 Abbott Park Rd
Abbott Park, Illinois 60064-3502
For Additional Information Contact Customer Service
877-422-2688
Manufacturer Reason
for Recall
Abbott has confirmed that a performance shift in the ARCHITECT Intact PTH assay has the potential to generate falsely elevated results on patient samples. Results generated with impacted lots may demonstrate a positive shift relative to those generated with previous reagent and/or calibrator lots. The issue may also impact your established ARCHITECT Intact PTH reference ranges. Abbott ARCHITECT In
FDA Determined
Cause 2
OTHER/UNDETERMINED: Under Investigation by the firm
Action Product Information letters dated August 23, 2013 were sent to all direct accounts alerting the direct accounts to a positive bias observed in test results using some of the affected kits. The letter advised the direct accounts to take this information into account when interpreting patient results. Customers with questions were advised to contact Customer Service at 877-4ABBOTT (877-422-2688) (24 hours a day, 7 days a week) and to refer to Product Information Letter PI23AUG2013. Product Recall letters dated February 12, 2014 were sent to all direct accounts. The letter included instructions to: 1) immediately discontinue the use of, and destroy, any remaining inventory of ARCHITECT Intact PTH assay according to each customer's laboratory practices; 2) to continue Intact PTH testing at your laboratory, Abbott recommends that customers identify an alternate method for testing patient samples; 3) if further guidance is needed, please contact the customers's Abbott sales representative; 4) review the letter with the treating physician or healthcare provider to ensure they are aware of the issue and can determine whether re-evaluation of the patient is necessary, and that Abbott included a physician letter that you can use to notify your ordering physicians of this issue; 5) If the customer forwarded any product to other laboratories, please inform them of this Product Recall and provide a copy of the recall letter, customer reply, and physician letter to them; and, 6) complete and return the Customer Reply. Customers with questions were advised to contact Customer Service at 877-4ABBOTT (877-422-2688) (24 hours a day, 7 days a week).
Quantity in Commerce 1) List Number 08K25-20: 6,433 assay kits; 2) List Number 08K25-25: 20,124 assay kits; 3) List Number 08K25-27: 10,968 assay kits
Distribution Worldwide Distribution - US Nationwide including District of Columbia and Puerto Rico; Algeria, Andorra, Angola, Argentina, Armenia, Austria, Azerbaijan, Bahamas, Bangladesh, Barbados, Belarus, Belgium, Bosnia & Herzegovina, Brazil, Brunei, Bulgaria, Cameroon, Canada, Cayman Islands, Chile, China, Colombia, Costa Rica, Croatia, Cyprus, Czech Republic, Denmark, Dominican Republic, Ecuador, Egypt, El Salvador, Ethiopia, Finland, France, Gaza and Jericho, Georgia, Germany, Greece, Guatemala, Honduras, Hong Kong, Hungary, India, Indonesia, Iran, Iraq, Ireland, Israel, ITALY, Jamaica, Japan, Jordan, Kenya, Korea (South Korea), Kuwait, Kyrgyzstan, Latvia, Lebanon, Libya, Lithuania, Luxembourg, Macedonia, Malaysia, Maldives, Mali, Mauritania, Mexico, Montenegro, Morocco, Netherlands, New Zealand, Norway, Oman, Pakistan, Palestine, Panama, Panam®, Paraguay, Peru, Philippines, Poland, Portugal, Qatar, Romania, Russia, San Marino, Saudi, Senegal, Serbia, Singapore, Slovakia, Slovenia, South Africa, SPAIN, Sri Lanka, Sweden, Switzerland, Taiwan, Thailand, Trinidad and Tobago, Tunisia, Turkey, United Arab Emirates, United Kingdom, Ukraine, Uruguay, Venezuela, Vietnam, and Yemen
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 = CEW and Original Applicant = BIOKIT S.A.
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