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Class 2 Device Recall NucliSensEasy Q Incubator |
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| Date Initiated by Firm |
February 26, 2004 |
| Date Posted |
July 20, 2004 |
| Recall Status1 |
Terminated 3 on March 24, 2004 |
| Recall Number |
Z-0735-04 |
| Recall Event ID |
28435 |
| Product Classification |
Colorimeter, Photometer, Spectrophotometer For Clinical Use - Product Code JJQ
|
| Product |
NucliSens¿Easy Q Incubator, Product Number 285204 (this number can be found at the back of the instrument). |
| Code Information |
Catalog (or Product) number 285204, Serial Number 36061, 36065 and 36068 |
Recalling Firm/
Manufacturer |
Biomerieux, Inc.
100 Rodolphe St
Durham NC 27712-9402
|
| For Additional Information Contact |
Anita M. McClernon, MS, RAC
919-620-2288
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Manufacturer Reason
for Recall |
Instrument malfunction. Electrical short circuit may occur resulting in damage or a fire hazard.
|
FDA Determined
Cause 2 |
Other |
| Action |
This correction is being handled as an instrument repair (rework) by bioMerieux Field Service; therefore no communication has been sent to the customer sites. The repair involves heat sink replacement or use of insulating tape on the rear side of the keypad. |
| Quantity in Commerce |
3 units |
| Distribution |
CT, MD, MT |
| Total Product Life Cycle |
TPLC Device Report
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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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