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U.S. Department of Health and Human Services

Class 3 Device Recall AutoDELFIA Neonatal IRT kit

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 Class 3 Device Recall AutoDELFIA Neonatal IRT kitsee related information
Date Initiated by FirmSeptember 25, 2017
Create DateOctober 11, 2018
Recall Status1 Terminated 3 on September 06, 2018
Recall NumberZ-1220-2018
Recall Event ID 79198
510(K)NumberK110274 
Product Classification N-Benzoyl-L-Arginine Ethyl Ester (U.V.), Trypsin - Product Code JNO
ProductAutoDELFIA Neonatal immunoreactive trypsin(ogen) (IRT) kit, intended for the quantitative determination of human immunoreactive trypsin(ogen) (IRT) in blood specimens. (UDI: (01)06438147298716(17)190430(10)656479); Product Number: B005-212
Code Information Lot Number: 656479, Batch Number: 1065647901, Expiration date: 2019-4-30
FEI Number 3002808498
Recalling Firm/
Manufacturer		 PerkinElmer Life and Analytical Sciences, Wallac, OY
Mustionkatu 6
P.O. Box 10
Turku Finland
Manufacturer Reason
for Recall		The Quality Control Certificate for certain AutoDELFIA Neonatal IRT Kits is missing information required to assess the acceptability of measured control values which may result in a delay in reporting IRT results.
FDA Determined
Cause 2		Process control
ActionActions to be taken: Inspect your inventory of AutoDELFIA Neonatal IRT kits for batch number 1065647901 and replace the Quality Control Certificate included in the kit packaging with the revised certificate attached to this letter. If you have already used the kit lot there is no need to retest the samples reported if the results of the controls included in the assay were within your established acceptance range. Complete and return the enclosed response form identifying the quantity of affected kits in your possession. Please inform others affected in your organization accordingly. To comply with regulatory requirements we require that you complete the enclosed Response Form and return it.
Quantity in Commerce240
DistributionDistributed to CT and TX.
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 = JNO
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