Medical device recalls Moderate risk

Perkinelmer Life Sciences, Inc. recalls Multiphor II Electrophoresis System GE HealthCare Product Number: 18-1018-06 PerkinElmer Part Number: 2117-004 Product…

Recall date
May 15, 2017
Source
U.S. Food & Drug Administration (FDA) — enforcement report
Recall number
Z-2685-2017
FDA classification
Class II
Brand / firm
Perkinelmer Life Sciences, Inc.
Sold / distributed
US Nationwide Distribution

Why it was recalled

Potential for electric shock in the case of a failure to install the grommets, supplied with the system.

Class II means using this product may cause temporary or medically reversible health problems; the chance of serious harm is remote.

What was recalled

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 electrophoresis and electrophoretic transfer Note: The Multiphor II Electrophoresis System (Class I) is the platform used with the hemoglobin electrophoresis gel kit ( Class II) sold by PerkinElmer as the Resolve Hemoglobin Kit (K050709: Product code JJN). The RESOLVE Systems Hemoglobin kit (K050709) is designed to separate whole blood, cord blood or dried blood spot specimen for detection of normal and variant hemoglobins by isoelectric focusing.

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