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U.S. Department of Health and Human Services

Class 2 Device Recall IMMULITE 2000/2000 XPi Intact Parathyroid Hormone (IPTH)

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 Class 2 Device Recall IMMULITE 2000/2000 XPi Intact Parathyroid Hormone (IPTH)see related information
Date Initiated by FirmNovember 22, 2016
Create DateJanuary 09, 2017
Recall Status1 Terminated 3 on May 25, 2018
Recall NumberZ-0979-2017
Recall Event ID 75837
510(K)NumberK013566 
Product Classification Radioimmunoassay, parathyroid hormone - Product Code CEW
ProductSIEMENS IMMULITE 2000/2000 Xpi Systems Intact PTH (Parathyroid Hormone) Test Code iPTH, REF/Catalog Number L2KPP2, Siemens Material Number (SMN) 10381441 and REF/Catalog Number L2KPP6, SMN 10381442; IVD --- Made in UK -- Siemens healthcare Diagnostics Products Ltd. Glyn Rhonwy, Llanberis, Gwynedd, LL55 4EL UK For in vitro diagnostic use with the IMMULITE 2000 Systems Analyzers - for the quantitative measurement of intact parathyroid hormone (parathyrin, PTH) in EDTA plasma and serum, as an aid in the differential diagnosis of hypercalcemia and hypocalcemia.
Code Information Lot Number 320, exp. date 2016/11/30;  UDI #s: 0063041496191032020161130 and 0063041496192732020161130 
Recalling Firm/
Manufacturer
Siemens Healthcare Diagnostics, Inc.
511 Benedict Ave
Tarrytown NY 10591-5005
Manufacturer Reason
for Recall
Siemens is conducting this recall for the IMMULITE 2000/IMMULITE 2000 XPi Intact PTH (Intact Parathyroid Hormone) (iPTH) assay kit lot 320. Siemens has confirmed that IMMULITE 2000/IMMULITE 2000 XPi Intact PTH kit lot 320 can exhibit an average negative bias of up to -39% at iPTH concentrations <20 pg/mL with serum and EDTA patient samples vs. a reference kit lot.
FDA Determined
Cause 2
Under Investigation by firm
ActionThe firm, Siemens, sent an "Urgent Medical Device Recall" letter IMC16-27.A.US (dated 11/22/2016) to its customers on 11/22/2016 via FedEx. Customers Outside the US were sent an "Urgent Field Safety Notice" dated 11/2016. The letter/notice describes the product, problem and actions to be taken. Customers were instructed to discontinue use of and discard the affected kit; review your inventory of these products to determine your laboratorys replacement needs; Complete and return the Field Correction Effectiveness Check Form attached to this letter within 30 days by fax to the Customer Care Center at (312) 275-7795; and retain this letter with your laboratory records, and forward this letter to those who may have received this product. If you have any questions, please contact your Siemens Customer Care Center or your local Siemens technical support representative.
Quantity in Commerce2728 kits (US: 565 kits; OUS: 2163 kits)
DistributionWorldwide Distribution: US (Nationwide) and countries of: Canada, China, Chile, Mexico, Australia, Austria, Bangladesh, Belgium, Bosnia Herzeg, Brazil, Bulgaria, Peru, Colombia, Ecuador, Bolivia, Costa Rica, Honduras, Croatia, Czech Republic, Denmark, Egypt, Estonia, France, Algeria, Greece, Guatemala, Hungary, India, Ireland, Israel, Italy, Japan, Kazakhstan, Latvia, Lebanon, Netherlands, Norway, Pakistan, Panama, Paraguay, Poland, Portugal, Republic Korea, Romania, Russian Fed., Serbia, Singapore, Slovakia, Slovenia, Spain, Sweden, Switzerland, Taiwan, Tunisia, Turkey, Jordan, U.A.E., United Kingdom and Uruguay.
Total Product Life CycleTPLC Device Report

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.
510(K) Database510(K)s with Product Code = CEW
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