FDA Device

D7120, BG-OX Cartridge, D7120 REF 946-003, and 946-001, cuvettes for the NPT7 series of blood gas analyzers.

Hazard

QC Bias-a solution used in the manufacturing of the membrane had a different composition which introduces a bias of 20 mpH.

What You Should Do

Remedy

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.

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Products

D7120, BG-OX Cartridge, D7120 REF 946-003, and 946-001, cuvettes for the NPT7 series of blood gas analyzers.
Brand
Radiometer America Inc
UPC
Lot R0187, Expiration Date: Sept. 2005; and Lot R0016, Expiration Date: 08/2005.

Units Affected

545

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