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U.S. Department of Health and Human Services

Class 3 Device Recall DELFIA PC with V3.0 Software

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 Class 3 Device Recall DELFIA PC with V3.0 Softwaresee related information
Date Initiated by FirmDecember 21, 2016
Create DateOctober 11, 2018
Recall Status1 Terminated 3 on October 03, 2018
Recall NumberZ-1102-2017
Recall Event ID 75949
510(K)NumberK935047 
Product Classification Fluorometer, for clinical use - Product Code KHO
ProductDELFIA PC with V3.0 Software, Fluorometer, for clinical use Product Number: 1235-8100 Product Usage: The Wallac 1235 AutoDELFIA automatic immunoassay system is designed to automatically perform assays using the DELFIA technology. DELFIA technology is based on the proven and widely used method of time resolved fluorometry
Code Information Batch Code US: 18RXWD2, 18TYWD2 OUS: B901XD2,18WYWD2, 18RXWD2
FEI Number 3006159931
Recalling Firm/
Manufacturer		 PerkinElmer Health Sciences, Inc.
940 Winter St
Waltham MA 02451-1457
For Additional Information ContactSAME
781-663-6900
Manufacturer Reason
for Recall		AutoDELFIA System with Version 3.0 Software: Potential plate loading failures
FDA Determined
Cause 2		Software design
ActionPerkinElmer issued letter on 12/21/16 to customers with AutoDELFIA Systems running version 3.0 Manager Software (revisons 1 and 2). The issue cannot be corrected by the customer therefore it is recommended the AutoDELFIA System be operated in the default English language variant until the AutoDELFIA Manager Software can be updated. The AutoDELFIA System with version 3.0 Manager Software performs as intended when the selected language variant is English. Customers are recommended to implement a software update to be deployed by PerkinElmer to resolve the issue. AutoDELFIA Manager Software version 3.0 revision 1 or 2 will be updated through the correction to revision 3 or the latest released revision
Quantity in Commerce1 US ; 3 OUS
DistributionWorldwide Distribution - US Nationwide in the state of MN and countries of China, India, Philippines, France, South Korea, Vietnam, Taiwan, Morocco, Kazachstan, UK, Spain, and Israel,
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 = KHO
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