FDA Medical Device Recalls (openFDA)
PerkinElmer Health Sciences, Inc.: 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
- Recall number
- Z-1102-2017
- Recalling firm
- PerkinElmer Health Sciences, Inc.
- 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
- Status
- Terminated
- Initiated
- 2016-12-21
- Posted
- not on file
- Terminated
- 2018-10-03
- Reason
- AutoDELFIA System with Version 3.0 Software: Potential plate loading failures
- 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
- 1 US ; 3 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,
- Lot, serial or model codes
- Batch Code US: 18RXWD2, 18TYWD2 OUS: B901XD2,18WYWD2, 18RXWD2
- 510(k) numbers
- ["K935047"]
- PMA numbers
- not on file
- Product code
- KHO
- Firm FEI
- 3006159931
- Firm city
- Waltham
- Firm state
- MA
- Firm country
- not on file
Where this comes from
- Register
- FDA Medical Device Recalls (openFDA)
- Publisher
- U.S. Food and Drug Administration (openFDA)
- File
- device-recall-0001-of-0001.json.zip
- sha256
- b87518bfe2e8
- Size
- 288210821 bytes
- Published
- 2026-09-28
- Read
- 2026-09-29T08:25:23.626Z
- Source file
- Source file retained · verify
- Refresh due
- 2026-10-06
Unless otherwise noted, the content, data, documentation, code, and related materials on openFDA is public domain and made available with a Creative Commons CC0 1.0 Universal dedication.
Cite as
FDA Medical Device Recalls (openFDA) (U.S. Food and Drug Administration (openFDA)), device-recall-0001-of-0001.json.zip, sha256 b87518bfe2e8, published 2026-09-28