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U.S. Department of Health and Human Services

Class 3 Device Recall Dritek D7120, BGOX Cartridges Qualicheck2

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  Class 3 Device Recall Dritek D7120, BGOX Cartridges Qualicheck2 see related information
Date Initiated by Firm January 12, 2005
Date Posted August 26, 2006
Recall Status1 Terminated 3 on September 14, 2011
Recall Number Z-1406-06
Recall Event ID 35664
510(K)Number K982928  
Product Classification Bllod gas analyzers - Product Code CHL
Product D7120, BG-OX Cartridge, D7120 REF 946-003, and 946-001, cuvettes for the NPT7 series of blood gas analyzers.
Code Information Lot R0187, Expiration Date: Sept. 2005; and Lot R0016, Expiration Date: 08/2005.
Recalling Firm/
Manufacturer		 Radiometer America Inc
810 Sharon Dr
Westlake OH 44145-1598
For Additional Information Contact Vince Sigmund
800-736-0600
Manufacturer 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.
FDA Determined
Cause 2		 Other
Action 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.
Quantity in Commerce 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, OH, OK, PA, SC, SD, TX, UT & WA.
Total Product Life Cycle TPLC Device Report
1 A record in this database is created when a firm initiates a correction or removal action. The record is updated if the FDA identifies a violation and classifies the action as a recall, and it is updated for a final time when the recall is terminated. Learn more about medical device recalls.
2 Per FDA policy, recall cause determinations are subject to modification up to the point of termination of the recall.
3 For details about termination of a recall see Code of Federal Regulations (CFR) Title 21 §7.55.
510(K) Database 510(K)s with Product Code = CHL and Original Applicant = RADIOMETER AMERICA, INC.
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