Radiometer America Inc D7120, BG-OX Cartridge, D7120 REF 946-003, and 946-001, cuvettes for the NPT7 series of blood gas analyzers. Recall
Check Your Product
According to the U.S. Food and Drug Administration (FDA)
Product
D7120, BG-OX Cartridge, D7120 REF 946-003, and 946-001, cuvettes for the NPT7 series of blood gas analyzers.
Brand
Radiometer America Inc
Lot Codes / Batch Numbers
Lot R0187, Expiration Date: Sept. 2005, and Lot R0016, Expiration Date: 08/2005.
Products Sold
Lot R0187, Expiration Date: Sept. 2005; and Lot R0016, Expiration Date: 08/2005.
Radiometer America Inc is recalling D7120, BG-OX Cartridge, D7120 REF 946-003, and 946-001, cuvettes for the NPT7 series of blood gas an due to QC Bias-a solution used in the manufacturing of the membrane had a different composition which introduces a bias of 20 mpH.. Based on FDA medical device recall database.
Summary derived from FDA notice
Reason for Recall
As stated by FDA
QC Bias-a solution used in the manufacturing of the membrane had a different composition which introduces a bias of 20 mpH.
Recommended Action
Per FDA guidance
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.
Verify this information on the official source
For complete details and official instructions, check the U.S. Food and Drug Administration (FDA) directly.
View official FDA recall noticePage updated: Jan 10, 2026