FDA Recall Terminated

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 Product Model Number: 0200086, 0200432, 0100007, 0100072 The Alere INRatio2 PT/INR Home Monitoring System is used for the quantitative measurement of Prothrombin Time (PT) in fresh, capillary whole blood. The Alere INRatio2 PT/INR Home Monitoring System is intended for use outside the body (in vitro diagnostic use) by people taking warfarin and other oral anticoagulant (blood thinning) therapy who need to monitor the clotting time of their blood. The Alere INRatio2 PT/ INR Home Monitoring System is not intended to be used for screening purposes. The Alere INRatio2 PT/INR Home Monitoring System should only be used with a prescription from your physician. The INRatio2 PT Monitoring system is used for the quantitative measurement of Prothrombin Time (PT) in fresh, capillary whole blood. The INRatio2 PT Monitoring system is intended for use outside the body (in vitro diagnostic use) by people taking warfarin and other oral anticoagulant (blood thinning) therapy who need to monitor the clotting time of their blood. The INRatio2 PT Monitoring System is not intended to be used for screening purposes. The INRatio2 PT Monitoring system should only be used with a prescription from your physician. The INRatio system performs Prothrombin Time (PT) testing on fresh, capillary whole blood. The PT test is the principle assay used to monitor warfarin therapy. Patients taking warfarin and other oral anticoagulants should consult with their healthcare provider before adjusting their dosage. The thromboplastins used in performing PT tests can vary substantially causing differences in results between methods. The International Normalized Ratio (INR) is a mathematical correction of the PT result that adjusts for differences in thromboplastins. Consult your physician for the appropriate therapeutic range for you.

Recall: Z-0188-2012 · Initiated October 11, 2011

Recall

Recall Number: Z-0188-2012
Event Number: 60370
Firm: Alere San Diego
FEI Number: 1000125596
Product Code: LKB
Status: Terminated
Root Cause: Material/Component Contamination
Initiated: October 11, 2011
Posted: November 16, 2011
Terminated: February 29, 2012
Address: 9975 Summers Ridge Rd, San Diego, CA, 92121-2997

Description

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.

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 include a sterile PDI alcohol pad. Customers were instructed to complete and FAX the enclosed Verification Form within 10 days to confirm their receipt of the notice and to indicate the number of discarded/required replacement alcohol prep pads. Customers with questions about INRatio/ INRatio 2 were instructed to consult their healthcare provider, or call Alere Technical Service at 877-866-5313 (24 hours a day, 7 days a week).

Distribution

Nationwide Distribution

Quantity

Estimated 14,248 Total units