Recall Z-2685-2017— Perkinelmer Life Sciences, Inc.

Name: FDA recall Z-2685-2017
Creator: U.S. Food and Drug Administration
Published: 2017-05-15

Class II · Terminated

Class II FDA medical device recall by Perkinelmer Life Sciences, Inc., initiated 2017-05-15, terminated 2023-03-02. It names one FDA 510(k) clearance: K050709. 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 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.. Reason: Potential for electric shock in the case of a failure to install the grommets, supplied with the system..

Recalling firm: Perkinelmer Life Sciences, Inc.
Classification: Class II
Status: Terminated
Initiated: 2017-05-15
Terminated: 2023-03-02
Firm location: Boston, MA, United States

510(k) clearances named in this recall

1 on FDA's record

K050709 — RESOLVE HEMOGLOBIN KIT, JB-2 STAINING SYSTEM, MODELS FR-9120, FR-9400, FR-9360, FR-9367Wallac OY·cleared 2006-03-08

K-numbers as listed on FDA's Recall Enterprise System record for this event (openFDA device/recall k_numbers). The recall may also cover devices cleared under other submissions not named here.

Product description

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.

Reason for recall

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

Data sourced from openFDA. This site is unofficial and independent of the FDA.