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U.S. Department of Health and Human Services

Class 2 Device Recall

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 Class 2 Device Recallsee related information
Date Initiated by FirmJanuary 30, 2007
Date PostedApril 05, 2007
Recall Status1 Terminated 3 on August 10, 2011
Recall NumberZ-0722-2007
Recall Event ID 37334
510(K)NumberK981759 
Product Classification in vitro diagnostic - Product Code CEO
ProductClinical 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 ContactIrene 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
ActionA 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 Commerce42020HW00 - 1,351 units worldwide; 44037HW00 - 314 units worldwide
DistributionWorldwide, including USA, Canada, Trinidad & Tobago, Bahamas, Panama, Cayman Islands, Jamaica
Total Product Life CycleTPLC 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) Database510(K)s with Product Code = CEO
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