| Date Initiated by Firm | March 04, 2004 |
|---|
| Date Posted | July 20, 2004 |
|---|
| Recall Status1 |
Terminated 3 on January 28, 2016 |
| Recall Number | Z-0737-04 |
|---|
| Recall Event ID |
28485 |
| 510(K)Number | K002400 |
|---|
| Product Classification |
System, Multipurpose For In Vitro Coagulation Studies - Product Code JPA
|
| Product | ACL Advance Instrument Analyzer |
|---|
| Code Information |
Software version prior to V2.1 |
| FEI Number |
1217183
|
Recalling Firm/
Manufacturer |
Instrumentation Laboratory Co.
113 Hartwell Ave
Lexington MA 02421-3125
|
| For Additional Information Contact | Carol Marble
781-861-4467 |
|---|
Manufacturer Reason
for Recall | Software may cause instrument to omit step causing reagent carrover which may effect patient test result |
|---|
FDA Determined
Cause 2 | Other |
|---|
| Action | Instrumentation Laboratory (IL) notified the Distributor Beckman Coulter, FL by letter on 3/9/04. Beckman will notify customers of the mandatory software upgrade by letter dated 3/4/04 with instructions for the software installation. |
|---|
| Quantity in Commerce | 760 units |
|---|
| Distribution | Florida
Canada |
|---|
| 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.
|
| 510(K) Database | 510(K)s with Product Code = JPA
|
|---|
