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 = and Original Applicant = ABX DIAGNOSTICS
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