Perkinelmer Life Sciences, Inc.: 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.

Recall number

Z-2685-2017

Recalling firm

Perkinelmer Life Sciences, Inc.

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.

Status

Terminated

Initiated

2017-05-15

Posted

2017-05-22

Terminated

2023-03-02

Reason

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

Root cause

Device Design

Action

Perkin Elmer issued URGENT: Field Correction letter on 5/15/17 and accompanied with the GE HealthCare Important Product Information letter The notifications will be delivered to the end customer by email facilitated through PerkinElmer Technical Support group located in Akron Ohio. Technical Support will ensure the customers receive the both letters and understand the recommended actions. Accounts requested to complete the enclosed Response Form. Questions regarding the actions to be taken, as outlined in the GE HealthCare letter, should be directed via email to orderFI@ge.com or via phone (in the US) 011 44 800 515313, (in the UK) 0800 515 313, and (rest of world) +44-800 515 313.

Quantity

241 instruments

Distribution

US Nationwide Distribution

Lot, serial or model codes

Serial Number: 1171221 1171231 1171232 1171234 1181923 1181925 1181928 1187499 1189475 1189484 1195060 1195074 1197741 1197743 1197752 1197753 1200106 1202993 1202994 1251991 1252000 1253298 1253301 1253307 1254797 1254798 1255972 1264957 1264960 1302820 1302823 1313213 1320921 1320925 1320927 1331757 1383503 1383506 1406432 1413361 1434395 1434396 1434399 1435683 1436876 1442735 1463140 1465792 1465793 1465794 1480331 1480829 1480834 1486179 1486180 1487157 1487158 1487159 1487160 1487161 1487162 1487182 1497464 1497490 1509220 1525734 1525737 1525739 1525741 1525744 1525745 1525748 1540014 1540016 1540018 1540019 1540020 1550838 1550839 1561681 1564304 1604476 1604481 1607341 1607345 1607346 1624871 1624873

510(k) numbers

["K050709"]

PMA numbers

not on file

Product code

JJN

Firm FEI

1000513616

Firm city

Boston

Firm state

MA

Firm country

not on file

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

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