Recall Z-2398-2010 ยท CEO Phosphomolybdate (Colorimetric), Inorganic Phosphorus
Abbott Laboratories Inc.
Clinical Chemistry Phosphorus assay
| Date | Sep 10, 2010 (initiated May 4, 2010) |
| Status | Terminated |
| Reason | Product may give inaccurate results and aspiration errors with reagent configuration, including results outside of linear range & calibration failure. |
| Root cause | Other |
| Action | Abbott Laboratories issued a "Product Recall: Immediate Action Required" letter dated May 4, 2010 to consignees. The letter described the product, problem and action to be taken by the customer. The letter instructed the customer to: 1) Identify affected product in inventory 2) Discontinue use and destroy any remaining inventory of the affected lot: 7D71-21 3) Complete and return an enclosed Customer Reply Form 4) Order alternative kit sizes for Clinical Chemistry Phosphorus: LN 7D71-31 or 7D71-22 5) For AEROSET Systems, manually update parameters as described in the letter. 6) For ARCHITECT |
| Quantity | 3136 |
| Distribution | Worldwide Distribution: US, including Puerto Rico, and countries of Germany, New Zealand, Trinidad/Tobago, Cayman Island, Hong Kong, Chile, Curacao, Jamaica, Australia, and Bahamas. |
| FDA record | Open on fda.gov |
510(k) clearances named in this recall
| K781000 | PHOSPHORUS (INORGANIC) ANALYSIS PRODUCTS Abbott Laboratories, Dec 4, 1978 |