| Date Initiated by Firm | January 17, 2003 |
|---|
| Date Posted | March 26, 2003 |
|---|
| Recall Status1 |
Terminated 3 on May 07, 2004 |
| Recall Number | Z-0678-03 |
|---|
| Recall Event ID |
25499 |
| Product Classification |
Calculator/Data Processing Module, For Clinical Use - Product Code JQP
|
| Product | Misys Laboratory,
Calculator/Data processing Module for Clinical Use (21 CFR 862.2100)
Misys Laboratory GUI Version 5.3 |
|---|
| Code Information |
Version 5.3 |
Recalling Firm/
Manufacturer |
Misys Healthcare Systems
4801 E Broadway Blvd
Tucson AZ 85711
|
| For Additional Information Contact | Cheryl Terpning
520-382-6218 |
|---|
Manufacturer Reason
for Recall | Software anomally. Graphical display omits results containing a less than (<), greater than (>) or percent (%) symbol. |
|---|
FDA Determined
Cause 2 | Other |
|---|
| Action | Firm sent notice by fax on 1/17/2003. The notice includes information about an effective workaround and indicates that the firm will announce the availability of a software correction when it''s ready. |
|---|
| Quantity in Commerce | 520 |
|---|
| Distribution | Nationwide and to United Kingdom, Ireland, Canada, Denmark, Saudi Arabia, United Arab Emirates. |
|---|
| Total Product Life Cycle | TPLC Device Report |
|---|
|
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.
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