| Date Initiated by Firm | June 19, 2007 |
|---|
| Date Posted | August 07, 2007 |
|---|
| Recall Status1 |
Terminated 3 on May 23, 2012 |
| Recall Number | Z-1127-2007 |
|---|
| Recall Event ID |
38234 |
| 510(K)Number | K063679 |
|---|
| Product Classification |
in vitro diagnostic - Product Code GKP
|
| Product | Instrumentation Laboratory ACL TOP Coagulation Analyzer (Base Model only). Blood analyzer.
P/N 280000 |
|---|
| Code Information |
Serial numbers prior to 07060782 |
| FEI Number |
1217183
|
Recalling Firm/
Manufacturer |
Instrumentation Laboratory Co.
113 Hartwell Ave
Lexington MA 02421-3125
|
| For Additional Information Contact | Debbie Herrera
305-380-4013 |
|---|
Manufacturer Reason
for Recall | ACL TOP unit, when in emergency stop may release liquid during recovery sequence and contaminate sample tube. |
|---|
FDA Determined
Cause 2 | Other |
|---|
| Action | Instrumentation Laboratory notiifed the distributor Beckman Coulter on 6/19/2007. Beckman Coulter notified their customers and provided a copy with the Instructions for Recovery Procedure on how to avoid contamination from probe leaks. |
|---|
| Quantity in Commerce | 94 |
|---|
| Distribution | Nationwide. |
|---|
| 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 = GKP
|
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