Recall Z-0188-2012 ยท LKB Pad, Alcohol, Device Disinfectant
Alere San Diego
PDI Alcohol Prep Pads packaged in the INRatio kit. PDI Alcohol Prep Pads, 100/box. Alcohol Prep Pads, packaged in the Alere INRatio 2 PT/INR Home Monitoring Kit; or Hemosense INRatio 2 Prothrombin Time/INR Testing Kit, Self-Test System; Alcohol Prep Pads, packaged in the Hemosense INRatio Prothrombin Time/INR Testing Kit, Self-Test System; Alcohol Prep Pads, packaged in the INRatio Starter Kit
| Date | Nov 16, 2011 (initiated Oct 11, 2011) |
| Status | Terminated |
| Reason | Alere has initiated a recall of the Professional Disposables International (PDI) alcohol prep products due to the potential presence of low levels of the microorganism Bacillus cereus. |
| Root cause | Material/Component Contamination |
| Action | Alere sent a recall notification letter dated October 6, 2011, and Verification Form to all affected customers. The letter identified the product, the problem, and the action to be taken by the customer. Customers were instructed to use an alternate prep pad that is not involved with the PDI recall, or use a sterile gauze pad with isopropyl alcohol. If customers purchase alcohol pads from a store or pharmacy, customers can confirm with their pharmacist that the pads they are purchasing are not associated with the PDI recall. INRatio/INRatio2 kits at Alere are currently being reworked to in |
| Quantity | Estimated 14,248 Total units |
| Distribution | Nationwide Distribution |
| FDA record | Open on fda.gov |