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U.S. Department of Health and Human Services

Class 2 Device Recall PDI Alcohol Prep Pads packaged in the INRatio kit.

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  Class 2 Device Recall PDI Alcohol Prep Pads packaged in the INRatio kit. see related information
Date Initiated by Firm October 11, 2011
Date Posted November 16, 2011
Recall Status1 Terminated 3 on February 29, 2012
Recall Number Z-0188-2012
Recall Event ID 60370
510(K)Number K020679  K021923  K072727  
Product Classification Pad, alcohol, device disinfectant - Product Code LKB
Product 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 INRatio¿2 PT/INR Home Monitoring System is used for the quantitative measurement of Prothrombin Time (PT) in fresh, capillary whole blood. The Alere INRatio¿2 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 INRatio¿2 PT/ INR Home Monitoring System is not intended to be used for screening purposes. The Alere INRatio¿2 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.
Code Information Lot/Unit Codes: 245765R, 245763R, 245766R, 245768, 245769, 252549, 245770, 252020, 252021, 252530, 252532, 252533, 256080, 256081, 256082, 256083, 256084, 256085, 260082, 256086, 256087, 256088, 256089, 256090, 256091, 256092, 261879, 261880.
Recalling Firm/
Manufacturer		 Alere San Diego
9975 Summers Ridge Rd
San Diego CA 92121-2997
For Additional Information Contact
858-455-4808 Ext. 3015
Manufacturer Reason
for Recall		 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.
FDA Determined
Cause 2		 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 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).
Quantity in Commerce Estimated 14,248 Total units
Distribution Nationwide Distribution
Total Product Life Cycle TPLC Device Report
1 A record in this database is created when a firm initiates a correction or removal action. The record is updated if the FDA identifies a violation and classifies the action as a recall, and it is updated for a final time when the recall is terminated. Learn more about medical device recalls.
2 Per FDA policy, recall cause determinations are subject to modification up to the point of termination of the recall.
3 For details about termination of a recall see Code of Federal Regulations (CFR) Title 21 §7.55.
510(K) Database 510(K)s with Product Code = LKB and Original Applicant = HEMOSENSE, INC.
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