Recalls / —
—#31890
Product
NucliSensEasy Q Incubator, Product Number 285204 (this number can be found at the back of the instrument).
- FDA product code
- JJQ — Colorimeter, Photometer, Spectrophotometer For Clinical Use
- Device class
- Class 1
- Medical specialty
- Clinical Chemistry
- Affected lot / code info
- Catalog (or Product) number 285204, Serial Number 36061, 36065 and 36068
Why it was recalled
Instrument malfunction. Electrical short circuit may occur resulting in damage or a fire hazard.
Root cause (FDA determination)
Other
Action the firm took
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.
Recalling firm
- Firm
- Biomerieux, Inc.
- Address
- 100 Rodolphe St, Durham, North Carolina 27712-9402
Distribution
- Distribution pattern
- CT, MD, MT
Timeline
- Recall initiated
- 2004-02-26
- Posted by FDA
- 2004-07-20
- Terminated
- 2004-03-24
- Status
- —
Source: openFDA Device Recall endpoint. Recall record ID #31890. The FDA issues recall classifications as health-hazard assessments, not legal findings; for legal claims consult a licensed attorney.