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Multiphor II Electrophoresis System GE HealthCare Product Number: 18-1018-06 PerkinElmer Part...

FDA Device Recall #Z-2685-2017 — Class II — May 15, 2017

Recall Summary

Recall Number Z-2685-2017
Classification Class II — Moderate risk
Date Initiated May 15, 2017
Status Terminated
Voluntary Voluntary: Firm initiated

Recalling Firm

Firm Perkinelmer Life Sciences, Inc.
Location Boston, MA
Product Type Devices
Quantity 241 instruments

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.

Distribution Pattern

US Nationwide Distribution

Lot / Code Information

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

Other Recalls from Perkinelmer Life Sciences, Inc.

Recall # Classification Product Date
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Frequently Asked Questions

Contact your physician immediately if you use an electrical device or implant affected by this recall. For external devices (monitors, pumps), stop using the device and contact the manufacturer for a replacement. For implanted devices (pacemakers, ICDs), your cardiologist will assess whether you need device replacement surgery — the decision depends on how dependent you are on the device and the actual failure rate observed in the field. Do not attempt to repair or modify a recalled electrical medical device yourself. Monitor for any new or unusual symptoms and report them to your doctor.

Class I recalls indicate a reasonable probability of serious adverse health consequences or death from the defect. Class II recalls involve products that may cause temporary or medically reversible adverse health consequences, or where serious consequences are remote. Class III recalls cover products not likely to cause any adverse health consequences, typically involving technical regulatory violations. The classification guides urgency — Class I recalls require immediate action, while Class III may simply involve returning a product or acknowledging a labeling change. Always read the specific recall notice for recommended patient actions.

Report problems with medical devices to the FDA through MedWatch at 1-800-FDA-1088 or online at FDA.gov/safety/medwatch. Healthcare facilities are required by law to report device-related serious injuries and deaths. Patients and consumers can also report voluntarily. Include the device name, manufacturer, model number, and a description of the problem and any patient outcome. Reports from patients and clinicians help the FDA identify emerging safety signals and may trigger investigations that lead to recalls of dangerous devices.

What Should You Do?

Stop using this device if you are affected by this recall. Contact your healthcare provider and the manufacturer immediately for guidance. Report adverse events to FDA MedWatch.

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