D7120, BG-OX Cartridge, D7120 REF 946-003, and 946-001, cuvettes for the NPT7 series of blood gas analyzers.
FDA device recall Z-1406-06 · posted 2006-08-26 · Terminated
Recall details
- Recalling firm
- Radiometer America Inc
- Reason for recall
- QC Bias-a solution used in the manufacturing of the membrane had a different composition which introduces a bias of 20 mpH.
- Action taken
- The firm contacted their customers and informed them of this problem and provided a workaround procedure, in a a letter dated 1/12/2005. A ''Field Action Notification'' (FAN) was issued to the firm''s Field Service personnel on 1/21/2005. The letter instructs their personnel to update the NPT7 application software on all units to V3.05 and to hand over a copy of the letter ''Changes related to the Qualicheck2+ and NPT7,'' to the user/customers. In addition, the firm''s personnel were instructed to remove any of the suspect cartridges found on-hand at each customer location; destroy them;and replace them with different lot numberd product.
- Root cause
- Other
- Status
- Terminated
- Product code
- CHL
- Quantity affected
- 545
- Distribution
- The recalled device component was distributed to a total of 56 customers, nationwide located in the following states: AL, AR, AZ, CA, CO, GA, ID, IL, KA, MA, ME, MI, MO, MS, NC, ND, NE, NH, NJ, NV, NY
- Date initiated
- 2005-01-12
- Date posted
- 2006-08-26
- Date terminated
- 2011-09-14
- Location
- Westlake, OH
Monitor recalls programmatically
Recalls and clearances share one API, with change alerts when new recalls post.
Related 510(k) clearances
| Record | Firm | Date |
|---|---|---|
| NPT7 SERIES PH/BLOOD GAS AND CO-OXIMETRY SYSTEM (K982928) | Radiometer America, Inc. | 1999-01-06 |