FDA Medical Device Recalls (openFDA)
Biomerieux, Inc.: NucliSensEasy Q Incubator, Product Number 285204 (this number can be found at the back of the instrument).
- Recall number
- Z-0735-04
- Recalling firm
- Biomerieux, Inc.
- Product
- NucliSensEasy Q Incubator, Product Number 285204 (this number can be found at the back of the instrument).
- Status
- Terminated
- Initiated
- 2004-02-26
- Posted
- 2004-07-20
- Terminated
- 2004-03-24
- Reason
- Instrument malfunction. Electrical short circuit may occur resulting in damage or a fire hazard.
- Root cause
- 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
- 3 units
- Distribution
- CT, MD, MT
- Lot, serial or model codes
- Catalog (or Product) number 285204, Serial Number 36061, 36065 and 36068
- 510(k) numbers
- not on file
- PMA numbers
- not on file
- Product code
- JJQ
- Firm FEI
- 1039284
- Firm city
- Durham
- Firm state
- NC
- Firm country
- not on file
Where this comes from
- Register
- FDA Medical Device Recalls (openFDA)
- Publisher
- U.S. Food and Drug Administration (openFDA)
- File
- device-recall-0001-of-0001.json.zip
- sha256
- b87518bfe2e8
- Size
- 288210821 bytes
- Published
- 2026-09-28
- Read
- 2026-09-29T08:25:23.626Z
- Source file
- Source file retained · verify
- Refresh due
- 2026-10-06
Unless otherwise noted, the content, data, documentation, code, and related materials on openFDA is public domain and made available with a Creative Commons CC0 1.0 Universal dedication.
Cite as
FDA Medical Device Recalls (openFDA) (U.S. Food and Drug Administration (openFDA)), device-recall-0001-of-0001.json.zip, sha256 b87518bfe2e8, published 2026-09-28