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U.S. Department of Health and Human Services

Class 2 Device Recall Perkin Elmer

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  Class 2 Device Recall Perkin Elmer see related information
Date Initiated by Firm January 10, 2019
Create Date April 27, 2019
Recall Status1 Open3, Classified
Recall Number Z-1239-2019
Recall Event ID 82064
510(K)Number K862044  
Product Classification Agglutination method, human chorionic gonadotropin - Product Code JHJ
Product AutoDELFIA¿ hCG Kit, In Vitro Diagnostic for the determination of human gonadotropin (hCG)
Product Code: B007-112 - Product Usage: Quantitative determination of human gonadotrophin (hCG).
Code Information Kit Lot Numbers: 664303 Pack Lot Numbers: 1066430301, 1066430302 UDI: (01)06438147009343(17)190430(10)664303
Recalling Firm/
Manufacturer		 PerkinElmer Life and Analytical Sciences, Wallac, OY
Mustionkatu 6
P.O. Box 10
Turku Finland
Manufacturer Reason
for Recall		 hCG analyte concentrations may be decreased up to 15- 20% at the lower measuring range of hCG concentrations.
FDA Determined
Cause 2		 Nonconforming Material/Component
Action Perkin Elmer initiated notification on January 10, 2018. The Recall Letter delivered to the end customer by email facilitated through the PerkinElmer Technical Support Group. PerkinElmer requires customers to: Inspect DELFIA / AutoDELFIA hCG kit inventory for the affected lots. Review your QC follow-up of the AutoDELFIA hCG assay for potential decrease in the control concentrations. If the control values are within your established acceptance range it is safe to report the results To avoid unnecessary repeat testing of samples, if the control values are out of the acceptance range discontinue use of the DELFIA / AutoDELFIA hCG kit lot and dispose the remaining kits of the lot. Complete the Response Form with the quantity of affected DELFIA / AutoDELFIA hCG kits you have disposed from your inventory
Quantity in Commerce 304 kits (United States)
Distribution Worldwide distribution - US Nationwide distribution. and countries of Austria, Bolivia, UK, Switzerland,Thailand, Finland.
Total Product Life Cycle TPLC 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 The manufacturer has initiated the recall and not all products have been corrected or removed. This record will be updated as the status changes.
510(K) Database 510(K)s with Product Code = JHJ and Original Applicant = LKB INSTRUMENTS, INC.
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