Recall Z-0722-2007 ยท CEO Phosphomolybdate (Colorimetric), Inorganic Phosphorus
Abbott Laboratories Inc.
Clinical Chemistry Phosphorus in vitro diagnostic, List Number: 7D71-30 and 7D71-20
| Date | Apr 5, 2007 (initiated Jan 30, 2007) |
| Status | Terminated |
| Reason | 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) |
| Root cause | 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. Custo |
| Quantity | 42020HW00 - 1,351 units worldwide; 44037HW00 - 314 units worldwide |
| Distribution | Worldwide, including USA, Canada, Trinidad & Tobago, Bahamas, Panama, Cayman Islands, Jamaica |
| FDA record | Open on fda.gov |
510(k) clearances named in this recall
| K981759 | PHOS Abbott Laboratories, Jun 16, 1998 |