D7120, BG-OX Cartridge, D7120 REF 946-003, and 946-001, cuvettes for the NPT7 series of blood gas analyzers.
This recall has been terminated (originally issued August 26, 2006).
- Company
- Radiometer America Inc
- Recall Initiated
- January 12, 2005
- Posted
- August 26, 2006
- Terminated
- September 14, 2011
- Recall Number
- Z-1406-06
- Quantity
- 545
- Firm Location
- Westlake, OH
- Official Source
- View on FDA website ↗
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.
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, OH, OK, PA, SC, SD, TX, UT & WA.
Lot / Code Info
Lot R0187, Expiration Date: Sept. 2005; and Lot R0016, Expiration Date: 08/2005.
Root Cause
Other
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.