Dri-Tek BG-OX Cartridge, Model #D7120, Cat. #946-003 Cartridges used in the NPT7 Analyzer, an in vitro diagnostic device
FDA device recall Z-1261-06 · posted 2006-07-27 · Terminated
Recall details
- Recalling firm
- Radiometer America Inc
- Reason for recall
- 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.
- Action taken
- 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.
- Root cause
- Other
- Status
- Terminated
- Product code
- CHL
- Quantity affected
- 185
- Distribution
- Nationwide.
- Date initiated
- 2006-05-01
- Date posted
- 2006-07-27
- Date terminated
- 2012-02-24
- Location
- Westlake, OH
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Related 510(k) clearances
| Record | Firm | Date |
|---|---|---|
| NPT7 SERIES PH/BLOOD GAS AND CO-OXIMETRY SYSTEM (K982928) | Radiometer America, Inc. | 1999-01-06 |