Quick Links: Skip to main page content Skip to Search Skip to Topics Menu Skip to Common Links
  • Decrease font size
  • Return font size to normal
  • Increase font size
U.S. Department of Health and Human Services

Class 3 Device Recall Qualicheck Level 2 control solution

  • Print
  • Share
  • E-mail
-
Super Search Devices@FDA
510(k) | DeNovo | Registration & Listing | Adverse Events | Recalls | PMA | HDE | Classification | Standards
CFR Title 21 | Radiation-Emitting Products | X-Ray Assembler | Medsun Reports | CLIA | TPLC
 


New Search Back to Search Results
  Class 3 Device Recall Qualicheck Level 2 control solution see related information
Date Initiated by Firm May 24, 2005
Date Posted August 02, 2006
Recall Status1 Terminated 3 on February 24, 2012
Recall Number Z-1316-06
Recall Event ID 35773
510(K)Number analyzer:K994346  K973742  K973367  
Product Classification package insert - Product Code GKF
Product Package Insert which accompanies the Hematocrit and Metabolite QUALICHECK LEVEL 2 Quality Control of Hematocrits and Metabolites, used with the ABL 77/70/555 Blood Gas & Electrolyte Analyzers. The QC reagents are packaged in a box of 30 glass vials of (1.5 ml) per box. The package insert is packed one per box.
Code Information Model #.S7180, Part Number: 944040, Lot #15.
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		 The package insert, which accompanied the QC reagents used with ABL blood gas analyzers, referenced incorrect control ranges for Hct (hematocrit) testing. The range stated on the package insert was too low to generate accurate Hct test results (The control ranges were acceptable for the glucose and lactate testing).
FDA Determined
Cause 2		 Other
Action The firm apprised their customers of this situation with a letter dated 5/24/2005. The letter requests that the customer remove the old (incorrect) package insert and replace it with a new (correct) insert which accompanied the customer letter. Should the customer have any questions, or need additional package inserts, the letter provides a toll-free contact telephone number.
Quantity in Commerce 55 boxes x 1 package insert per box
Distribution Nationwide, including: PA, MI, NY, OH, NJ, TX, AL, MO, AR, TN, WA, KY, and NC, and London, ON, Canada
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 = GKF and Original Applicant = RADIOMETER AMERICA, INC.
510(K)s with Product Code = GKF and Original Applicant = SENDX MEDICAL, INC.
-
-