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 2 Device Recall

  • 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 2 Device Recall see related information
Date Initiated by Firm January 30, 2007
Date Posted April 05, 2007
Recall Status1 Terminated 3 on August 10, 2011
Recall Number Z-0722-2007
Recall Event ID 37334
510(K)Number K981759  
Product Classification in vitro diagnostic - Product Code CEO
Product Clinical Chemistry Phosphorus in vitro diagnostic, List Number: 7D71-30 and 7D71-20
Code Information 42020HW00 & 44037HW00
Recalling Firm/
Manufacturer		 Abbott Laboratories Inc.
820 Mission St
South Pasadena CA 91030-3142
For Additional Information Contact Irene Powers
847-937-1998
Manufacturer Reason
for Recall		 Patient results are falsely decreased by up to 15% at these levels: 1) Serum Plasma phosphorus greater than 8.0 mg/dL (2.60 mmol/L) 2) Urine phosphorus greater than 80.0 mg/dL (25.80 mmol/L)
FDA Determined
Cause 2		 Other
Action A Product Correction letter dated January 30, 2007 provided to all Clinical Chemistry Phosphorus customers that have received lot numbers 42020HW00 and 44037HW00 stating that patient results are falsely decreased by up to 15% at these levels: Serum/Plasma phosphorus greater than 8.0 mgldL (2.60 mmol/L) and Urine phosphorus greater than 80.0 mg/dl. (25.80 mmol/L). Modified linearity ranges are provided in the letter that are to be implemented when using the two lots. Instructions are also provided for changing the linearity range on the Architect cSystem as well as the Aeroset System. Customers are instructed that If they have forwarded any of Information the Clinical Chemistry Phosphorus lots listed above to another laboratory to provide a copy of this letter to them. A customer response form is provided.
Quantity in Commerce 42020HW00 - 1,351 units worldwide; 44037HW00 - 314 units worldwide
Distribution Worldwide, including USA, Canada, Trinidad & Tobago, Bahamas, Panama, Cayman Islands, Jamaica
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 = CEO and Original Applicant = ABBOTT LABORATORIES
-
-