Date Initiated by Firm | January 20, 2003 |
Date Posted | February 25, 2003 |
Recall Status1 |
Terminated 3 on July 26, 2003 |
Recall Number | Z-0570-03 |
Recall Event ID |
25485 |
510(K)Number | K003677 |
Product | AcT 5 diff Cap Pierce Hematology Analyzer
864.5220 Automated differential cell counter |
Code Information |
Not applicaable. |
Recalling Firm/ Manufacturer |
Beckman Coulter Inc 200 South Kraemer Blvd W 337 Brea CA 92822
|
For Additional Information Contact | Lynne McBride 714-961-3626 |
Manufacturer Reason for Recall | Failure to cycle properly ammong samples. |
FDA Determined Cause 2 | Other |
Action | Customers were sent a letter dated January 20, 2003 that describes this situation and provides modified operating instructions to prevent the occurence. |
Quantity in Commerce | 351 |
Distribution | US and Canada |
|
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. 3 For details about termination of a recall see Code of Federal Regulations (CFR) Title 21 §7.55.
|
510(K) Database | 510(K)s with Product Code =
|