Date Initiated by Firm |
January 10, 2019 |
Create Date |
April 27, 2019 |
Recall Status1 |
Open3, Classified |
Recall Number |
Z-1237-2019 |
Recall Event ID |
82064 |
510(K)Number |
K862044
|
Product Classification |
Agglutination method, human chorionic gonadotropin - Product Code JHJ
|
Product |
DELFIA¿ hCG Kit, In Vitro Diagnostic for the determination of human gonadotropin (hCG) Product Code: A007-101 - Product Usage: Quantitative determination of human gonadotrophin (hCG) in serum.
|
Code Information |
Kit Lot Numbers: 664891, 666471, 666604 Pack Lot Numbers: 1066489101, 1066647101,1066660401 UDI: (01)06438147009176(17)190430(10)664891 (01)06438147009176(17)190430(10)666471 (01)06438147009176(17)190430(10)666604 |
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 |
31 kits (10 in US, 21 in ROW) |
Distribution |
Worldwide distribution - US Nationwide distribution. and countries of Austria, Bolivia, UK, Switzerland,Thailand, Finland. |
Total Product Life Cycle |
TPLC Device Report
|
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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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