PerkinElmer AutoDELFIA System Recalled for Potential Plate Loading Failures
PerkinElmer is recalling AutoDELFIA systems with V3.0 software due to potential plate loading failures that could affect clinical assay results.
The agency’s classification
FDA (Devices): Class III
Class III is a situation in which use of or exposure to a violative product is not likely to cause adverse health consequences.
This is the agency’s own classification, taken from its notice. The severity score below is our assessment, not the agency’s. How recall classes work
What this means for you
Our assessment, not the agency’s: severity 1/5 (Low).
Cosmetic or documentation issue. No expected health impact, but the manufacturer is correcting the affected products.
Our severity reasoning: The agency classification is Class III, which the rubric defines as typically unlikely to cause adverse health consequences. The source text does not report any injuries, illnesses, or deaths.
Plain-English summary
PerkinElmer Health Sciences, Inc. is recalling the AutoDELFIA System with Version 3.0 Software (Product Number: 1235-8100). The recall is due to potential plate loading failures in the automatic immunoassay system.
The affected units were distributed worldwide, including in the United States (specifically Minnesota) and in China, India, the Philippines, France, South Korea, Vietnam, Taiwan, Morocco, Kazakhstan, the UK, Spain, and Israel. The recall involves specific batch codes: 18RXWD2 and 18TYWD2 for US units, and B901XD2, 18WYWD2, and 18RXWD2 for units outside the US.
Healthcare facilities and users of the AutoDELFIA system should contact PerkinElmer Health Sciences, Inc. for instructions on how to address the potential plate loading failures. The source text does not specify the exact remediation steps or report any illnesses or injuries associated with this recall.
The recalled product
- 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…
- Manufacturer
- PerkinElmer Health Sciences, Inc.
- Hazard
Is your product affected?
Check your packaging against the codes below. If any of them match, the product is part of this recall.
Lot numbers (4)
- Batch Code US: 18RXWD2
- 18TYWD2 OUS: B901XD2
- 18WYWD2
- 18RXWD2
Distribution
Part of a larger recall action
This product is one of 3 recalled by PerkinElmer Health Sciences, Inc. under a single FDA (Devices) recall action. The agency files each product separately, so the size of the action is not visible from this page alone.
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