Clinical Chemistry Phosphorus in vitro diagnostic, List Number: 7D71-30 and 7D71-20 의 리콜

Recall

37334

Class 2

Z-0722-2007

2007-01-30

2007-04-05

Terminated

United States

2011-08-10

USFDA

https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfres/res.cfm?id=50375

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).

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.