Recall Z-2685-2017 ยท JJN Apparatus, Electrophoresis, For Clinical Use
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 wit
| Date | May 22, 2017 (initiated May 15, 2017) |
| Status | Terminated |
| 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 p |
| Quantity | 241 instruments |
| Distribution | US Nationwide Distribution |
| FDA record | Open on fda.gov |
510(k) clearances named in this recall
| K050709 | RESOLVE HEMOGLOBIN KIT, JB-2 STAINING SYSTEM, MODELS FR-9120, FR-9400, FR-9360, FR-9367 Wallac OY, Mar 8, 2006 |