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U.S. Department of Health and Human Services

Class 3 Device Recall PerkinElmer DELFIA hFSH kit

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 Class 3 Device Recall PerkinElmer DELFIA hFSH kitsee related information
Date Initiated by FirmNovember 16, 2016
Date PostedDecember 16, 2016
Recall Status1 Terminated 3 on July 05, 2017
Recall NumberZ-0779-2017
Recall Event ID 75708
510(K)NumberK862043 
Product Classification Radioimmunoassay, follicle-stimulating hormone - Product Code CGJ
ProductDELFIA hFSH kit. In Vitro Diagnostic for the determination of hFSH in serum
Code Information Lot Number: 646091
Recalling Firm/
Manufacturer		 PerkinElmer Health Sciences, Inc.
940 Winter St
Waltham MA 02451-1457
For Additional Information Contact
781-663-6900
Manufacturer Reason
for Recall		A DELFIA hFSH kit lot failed real time stability testing. The real time stability data demonstrated a decrease in hFSH concentrations between -4.8% to -11.3% for control sera. The -11.3% bias was observed at an hFSH target concentration of 101 IU/L. The change observed in the serum samples within the range 1.76  67.0 IU/L hFSH averaged -2.9%. The reference range of the assay spans 0.60 to 98.0 IU/L.
FDA Determined
Cause 2		Other
ActionPerkinElmer initiated recall on November 16, 2016, delivered to the end customer by email facilitated through the PerkinElmer Technical Support group located in Akron Ohio. Technical Support will be asked to make sure the customers receive the Recall Letter and understand the recommended actions. Users asked to inspect inventory, discontinue use destroy the kits and complete the Response Forms and Destruction.Replacement kits will shipped.
Quantity in Commerce79 kits
DistributionCA, CO, NY, WA Foreign: Austria, Bolivia, Bosnia , Sweden, Norway, Netherlands, Japan, Great Britain,
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 = CGJ
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