| Date Initiated by Firm | December 16, 2005 |
|---|
| Date Posted | January 11, 2006 |
|---|
| Recall Status1 |
Terminated 3 on May 21, 2007 |
| Recall Number | Z-0378-06 |
|---|
| Recall Event ID |
34249 |
| 510(K)Number | K052121 |
|---|
| Product Classification |
Glucose Oxidase, Glucose - Product Code CGA
|
| Product | GEM PREMIER 3000 |
|---|
| Code Information |
Serial numbers starting with 18412 |
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 error may report higher results for glucose and lactate |
|---|
FDA Determined
Cause 2 | Other |
|---|
| Action | Instrumentation Laboratory notified customers by letter dated December 2005 on 12/16/2005. Customers were notifed if the error message occurs the lab should diable the glucose and lactate channels or remove cartridge. A software upgrade will be released in early 2006. |
|---|
| Quantity in Commerce | 2021 units |
|---|
| Distribution | Nationwide
Foreign: 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 = CGA
|
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