AutoMate 2500 Family Catalog No. ODL25120 AutoMate 1200, ODL25125, AutoMate 1250, ODL25250 AutoMate 2500, ODL25255 Autom
FDA device recall Z-1040-2017 · posted 2017-01-18 · Terminated
Recall details
- Recalling firm
- Beckman Coulter Inc.
- Reason for recall
- Beckman Coulter initiated a design change to update the Automate PC image to accommodate the operating system change to Windows 10.
- Action taken
- The firm, Beckman Coulter, initiated a cite visit to correct the 4 systems installed. The firm will perform the correction by Field Service and tracked via Service Modification. If you have any questions, contact the VP, Global Quality Systems & Compliance at 714-961-4933 or email: RegulatoryAgencyInquiries@beckman.com.
- Root cause
- Under Investigation by firm
- Status
- Terminated
- Product code
- JQP
- Quantity affected
- 4 units
- Distribution
- US Distribution to MD only.
- Date initiated
- 2016-12-21
- Date posted
- 2017-01-18
- Date terminated
- 2017-05-17
- Location
- Brea, CA
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