Multiphor II Electrophoresis System GE HealthCare Product Number: 18-1018-06 PerkinElmer Part Number: 2117-004 Product U
FDA device recall Z-2685-2017 · posted 2017-05-22 · Terminated
Recall details
- Recalling firm
- Perkinelmer Life Sciences, Inc.
- Reason for recall
- Potential for electric shock in the case of a failure to install the grommets, supplied with the system.
- Action taken
- 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.
- Root cause
- Device Design
- Status
- Terminated
- Product code
- JJN
- Quantity affected
- 241 instruments
- Distribution
- US Nationwide Distribution
- Date initiated
- 2017-05-15
- Date posted
- 2017-05-22
- Date terminated
- 2023-03-02
- Location
- Boston, MA
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Related 510(k) clearances
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| RESOLVE HEMOGLOBIN KIT, JB-2 STAINING SYSTEM, MODELS FR-9120, FR-9400, FR-9360, FR-9367 (K050709) | Wallac OY | 2006-03-08 |