PerkinElmer Multiphor II Electrophoresis System Recalled for Electric Shock Risk
PerkinElmer is recalling 241 Multiphor II Electrophoresis Systems due to a potential electric shock hazard if grommets are not installed.
The agency’s classification
FDA (Devices): Class II
Class II is a situation in which use of or exposure to a violative product may cause temporary or medically reversible adverse health consequences, or where the probability of serious adverse health consequences is remote.
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 3/5 (High).
Real risk of harm even if no illness or injury has been reported yet. Stop using the product and follow the agency's guidance.
Our severity reasoning: The recall involves a risk-of-harm product (electric shock) where injury has not yet been reported, which aligns with the 'High' severity criteria in the rubric.
Plain-English summary
Perkinelmer Life Sciences, Inc. is recalling 241 Multiphor II Electrophoresis Systems (GE HealthCare Product Number: 18-1018-06; PerkinElmer Part Number: 2117-004). The recall was initiated because of a potential for electric shock in the case of a failure to install the grommets, which are supplied with the system.
The affected instruments were distributed nationwide in the United States. The Multiphor II Electrophoresis System is a modular electrophoresis system used for horizontal electrophoresis, isoelectric focusing, 2-D electrophoresis, and electrophoretic transfer. It serves as the platform for the Resolve Hemoglobin Kit, which is designed to separate blood specimens for the detection of normal and variant hemoglobins.
Users should check their serial numbers against the list provided in the official recall notice to determine if their instrument is affected. If the serial number matches, users should contact Perkinelmer Life Sciences, Inc. for instructions on how to resolve the issue.
The recalled product
- Product
- Multiphor II Electrophoresis System GE HealthCare Product Number: 18-1018-06 PerkinElmer Part Number: 2117-004 Product Usage: Multiphor II Electrophoresis System is a versatile modular electrophoresis system for horizontal electrophoresis, isoelectric focusing, 2-D…
- Manufacturer
- Perkinelmer Life Sciences, Inc.
- Hazard
- Affected units
- 241
Distribution
Distributed nationwide across the United States.
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