FDA Medical Device Recalls (openFDA)
Radiometer America Inc: Dri-Tek BG-OX Cartridge, Model #D7120, Cat. #946-003 Cartridges used in the NPT7 Analyzer, an in vitro diagnostic device.
- Recall number
- Z-1261-06
- Recalling firm
- Radiometer America Inc
- Product
- Dri-Tek BG-OX Cartridge, Model #D7120, Cat. #946-003 Cartridges used in the NPT7 Analyzer, an in vitro diagnostic device.
- Status
- Terminated
- Initiated
- 2006-05-01
- Posted
- 2006-07-27
- Terminated
- 2012-02-24
- Reason
- Air bubbles may be trapped on or close to the O2 sensor in the pO2 chamber of the cuvettes in cartridges used for blood gas analysis on NPT7 analyzer. This produces too high pO2 readings without a question mark.
- Root cause
- Other
- Action
- The recalling firm initiated this recall with a letter to send to their customers, via Registered Mail, on 5/1/2006. The letter requests that the customers identify and discard the potentially defective cartridges from Lot #R0299. The letter is accompanied by a recall response page to be completed by the customer and faxed or mailed back to the Radiometer so that the customer can receive an equal number of replacement cartridges free-of-charge.
- Quantity
- 185
- Distribution
- Nationwide.
- Lot, serial or model codes
- D7120 946-003 Cartridges, Lot #R0299, Expiration Date: 02/2008.
- 510(k) numbers
- ["K982928"]
- PMA numbers
- not on file
- Product code
- CHL
- Firm FEI
- 1523456
- Firm city
- Westlake
- Firm state
- OH
- 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