| Class 2 Device Recall NucliSensEasy Q Incubator | |
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
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Product | NucliSensEasy 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 |
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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