PerkinElmer Health Sciences, Inc.: AutoDELFIA System with Version 3.0 Software: Potential plate loading failures

Agency Publication Date: October 11, 2018

Affected Products

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

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

Product: Program Update Package AutoDELFIA¿ 3.0, Fluorometer, for clinical use Product Number: 1235-8110 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

Batch Code: 649552 OUS: 649552, 649552

Lot Numbers:

Code

Product: DELFIA¿ 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

Batch Code US: 18RXWD2, 18TYWD2 OUS: B901XD2,18WYWD2, 18RXWD2

Lot Numbers:

Code

Additional Information

Agency: Food and Drug Administration (FDA)

Event ID: 75949

Status: Resolved

Manufacturer: PerkinElmer Health Sciences, Inc.

Manufactured In: United States

Units Affected: 3 products (1 unit (US) 6 (OUS); 1 unit (US) 2 units (OUS); 1 US ; 3 OUS)

AI-Enhanced Content: The summary, action steps, and risk assessment on this page were generated by AI from official government recall data to improve readability. This is not legal or medical advice. Always refer to the official agency sources below for authoritative information.

Sources: FDA iRES · Raw API Response

openFDA Disclaimer: This recall information is sourced from the openFDA API. Do not rely on openFDA to make decisions regarding medical care. While we make every effort to ensure that data is accurate, you should assume all results are unvalidated. Refer to the openFDA terms of service for more information.

Affected Products

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

Batch Code: 649552 OUS: 649552, 649552

Lot Numbers:

Code

Batch Code US: 18RXWD2, 18TYWD2 OUS: B901XD2,18WYWD2, 18RXWD2

Lot Numbers:

Code