Z-1100-2017Class III

AutoDELFIA Plate Processor , Fluorometer, for clinical use Product Number: 1235-5110

Name: Z-1100-2017 AutoDELFIA Plate Processor , Fluorometer, for clinical use Product Number: 1235-5110
Creator: PerkinElmer Health Sciences, Inc.
Published: 2016-12-21
License: https://open.fda.gov/license/

Revvity Health Sciences, Inc. / initiated 2016-12-21 / Terminated / root cause: software

FDA source

PerkinElmer Health Sciences, Inc. began a recall of AutoDELFIA Plate Processor , Fluorometer, for clinical use Product Number: 1235-5110 Product Usage: The Wallac 1235 AutoDELFIA automatic immunoassay system is... on 2016-12-21. FDA classified it as Class III and gives the reason as "AutoDELFIA System with Version 3.0 Software: Potential plate loading failures". As of 2026-09-10, the recall status on record is Terminated, and MDM tags the root cause as software.

Recall record

Recall number: Z-1100-2017
Classification: Class III
Status: Terminated
Initiated: 2016-12-21
Posted: 2018-10-11
Terminated: 2018-10-03
Recalling firm: Revvity Health Sciences, Inc.
Product: AutoDELFIA Plate Processor , Fluorometer, for clinical use Product Number: 1235-5110 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
Product code: KHO Fluorometer, For Clinical Use
Reason for recall: AutoDELFIA System with Version 3.0 Software: Potential plate loading failures
Root cause tag: software
FDA root cause: Software design
Action: PerkinElmer 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 commerce: 1 unit (US) 6 (OUS)
Distribution: Worldwide 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,
Product codes and lots: AutoDELFIA¿ Plate Processor 1235-5110 UDI:(01)06438147334766, (21)2352016 Serial Number: 2352016 (US) Serial Numbers: OUS: s/n: 2352014, 2352046, 2352048,2352054, 2352056, 2352059

Enforcement reports

One row per recalled product line

FDA enforcement reports joined to recall event Z-1100-2017
Recall number	Class	Status	Voluntary or mandated	Report date	Classified
Z-1100-2017	Class III	Terminated	Voluntary: Firm initiated	2017-02-01	2017-01-26
Z-1101-2017	Class III	Terminated	Voluntary: Firm initiated	2017-02-01	2017-01-26
Z-1102-2017	Class III	Terminated	Voluntary: Firm initiated	2017-02-01	2017-01-26

Product code KHO

K935047Class IAuto DelfiaWallac OY / cleared 1994-05-23

MDM coverage of this record lists here, newest first.

About this record

Sourced from the FDA device recall database and the FDA enforcement reports, both ingested from openFDA. The recall record supplies the product, the reason and the product code; the enforcement report supplies the classification. The two datasets are exported by FDA on different days, and the date above is the older of the two, so nothing on this page is newer than it says.

MDM adds the root cause tag, derived from FDA’s own root cause text, and the cross-links to the product code, the clearances named on the record and MDM coverage. Where a recall has not been joined to an enforcement report, no classification is shown.

Data as of 2026-09-30, the FDA export date for this dataset. Page last changed 2026-09-05. View this recall on fda.gov (opens on fda.gov)