Recall Z-3278-2011 ยท CJE Nitrophenylphosphate, Alkaline Phosphatase Or Isoenzymes
Abbott Laboratories, Inc
Clinical Chemistry Alkaline Phosphatase, List Number 7D55-21 & 7D55-31. Used for the quantitation of alkaline phosphatase in human serum or plasma.
| Date | Sep 26, 2011 (initiated Aug 26, 2011) |
| Status | Terminated |
| Reason | The reagent has the potential to be contaminated with mold, the Cladosporium fungal species. |
| Root cause | Pending |
| Action | The firm decided to recall and notified consignees by a Product Recall - Immediate Action Required letter on 08/26/11. The letter identified the affected product, the reason for the recall, the patient impact, and necessary actions to be taken by the customer. Customers are to determine if they are using or have the affected product in their inventory. Customers are to discontinue use and destroy any remaining product of the specified lots in accordance with their facility's policies and procedures. Alternative lots of the product should be ordered and the enclosed Customer Reply form shou |
| Quantity | 6269 units |
| Distribution | Worldwide Distribution |
| FDA record | Open on fda.gov |
510(k) clearances named in this recall
| K981806 | ALKP Abbott Laboratories, Jun 22, 1998 |