| Class 2 Device Recall AutoMate 2500 Family |  |
Date Initiated by Firm | January 19, 2018 |
Create Date | March 22, 2018 |
Recall Status1 |
Completed |
Recall Number | Z-1169-2018 |
Recall Event ID |
79006 |
Product Classification |
Calculator/data processing module, for clinical use - Product Code JQP
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Product | AutoMate 1200 Catalog Number ODL25120;
AutoMate 1250 Catalog Number ODL25125;
AutoMate 2500 Catalog Number ODL25250;
AutoMate 2550 Catalog Number ODL25255 |
Code Information |
All systems up to the following Serial Numbers: ODL25120 Revision T; SN3101, ODL25125 Revision W; SN1508, ODL25250 Revision T; SN2416, ODL25255 Revision W; SN4617 |
Recalling Firm/ Manufacturer |
Beckman Coulter Inc. 250 S Kraemer Blvd Brea CA 92821-6232
|
For Additional Information Contact | Customer Service 469-961-4941 |
Manufacturer Reason for Recall | Belts on the x-axis (and on the y-axis, to a lesser extent) manufactured from 2015 are showing premature failure, posing the remote risk of cross-contamination. |
FDA Determined Cause 2 | Device Design |
Action | Beckman Coulter plans to replace the belt via Service Modification during the next planned service maintenance visit. At that time, the customer will be informed of the belt replacement by the service engineer. |
Quantity in Commerce | 98 units in the US |
Distribution | Australia, Austria, Belarus,
Belgium, Bosnia and Herzegovina, Brazil,
Canada, China, Croatia,
Cyprus, Czech Republic, Denmark,
Finland, France, Germany,
Gibraltar, Greece, Hong Kong,
Hungary, India, Ireland,
Israel, Italy, Korea,
Kuwait, Latvia, Lithuania,
Macao, Mayotte, Mexico,
Netherlands, New Zealand, Norway,
Panama, Poland, Portugal,
Qatar, Russia, Saudi Arabia,
Singapore, Slovakia, Slovenia,
South Africa, Spain, Sweden,
Switzerland, Taiwan, Turkey,
United Kingdom, United States |
Total Product Life Cycle | TPLC Device Report |
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1 A record in this database is created when a firm initiates a correction or removal action. The record is updated if the FDA identifies a violation and classifies the action as a recall, and it is updated for a final time when the recall is terminated. Learn more about medical device recalls. 2 Per FDA policy, recall cause determinations are subject to modification up to the point of termination of the recall.
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