| Date Initiated by Firm | March 27, 2007 |
|---|
| Date Posted | May 03, 2007 |
|---|
| Recall Status1 |
Terminated 3 on May 23, 2012 |
| Recall Number | Z-0778-2007 |
|---|
| Recall Event ID |
37719 |
| 510(K)Number | K061974 |
|---|
| Product Classification |
Laboratory Analyzer - Product Code CHL
|
| Product | GEM Premier 4000 Laboratory Analyzer |
|---|
| Code Information |
Serial numbers prior to 07020343 with Software versions prior to V1.1.3 |
Recalling Firm/
Manufacturer |
Instrumentation Laboratory Co.
113 Hartwell Ave
Lexington MA 02421-3125
|
Manufacturer Reason
for Recall | Instrument in Micro Sampling Mode failed to aspirate and no error code was generated and an incorrect patient report could result |
|---|
FDA Determined
Cause 2 | Other |
|---|
| Action | Instrumentation Labs on 3/2707 notified Service Reps to perform on site mandatory upgrade. The foreign counterparts were advised by email on 3/21/07 |
|---|
| Quantity in Commerce | 210 |
|---|
| Distribution | Worldwide, including USA, Australia, Austria, Greece, Spain, Netherlands, Great Britain, France, Germany, Italy, and Sweden |
|---|
| 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 = CHL
|
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