Alere INRatio2 PT/INR Professional Test Strips - Results Disagree with the Confirmed PT/INR Reference Test Results Performed by Central Laboratory
Recall Class: Class I
Date Recall Initiated: April 16, 2014
Product: Alere INRatio2 PT/INR Professional Test Strips (PN 99008G2)
The Alere INRatio2 PT/INR Professional Test Strips are part of the Alere lNRatio2 PT/INR Monitoring System (Professional Use) which also consists of the INRatio2 Monitor.
This recall is expected to cause a shortage of test strips for the Alere INRatio2 professional PT/INR testing. Alere will transition customers from the current Alere INRatio2 PT/INR Professional Test Strip to the Alere INRatio PT/INR Test Strip (PN 100139) because the Alere INRatio PT/INR Test Strip is not affected by this recall.
The voluntary recall does not include the Alere INRatio PT/INR Test Strip (PN 100071) which is used by patient self-testers for home INR monitoring but has also been validated for professional use.
The affected test strips were manufactured from August 22, 2013 through April 2, 2014 and distributed from August 26, 2013 through April 2, 2014.
Lot Numbers: 324810, 324811, 324812, 327543, 327544, 327549, 328109, 328705, 328707, 330238, 330852, 331340, 331916, 331922, 332841, 332842, 332843, 332959, 333362, 333654, 333655, 333864, 333865, 334572, 334575, 335552, 335553, 335796, 335797, 336426, 336668, 337350, 338965, 338966, 339257, 339707, 327856V
Use: The Alere lNRatio2 PT/INR Monitoring System (Professional Use) is used for quantitative determination of international normalized ratio (INR) in fresh, capillary whole blood to monitor the effect of warfarin on clotting time (prothrombin time). The Alere INRatio2 PT/INR Monitoring System (Professional Use) is intended for use outside of the body (in vitro diagnostic use). The Alere INRatio2 PT/INR Monitoring System (Professional Use) is not intended to be used for screening purposes. The Alere INRatio2 PT/INR Monitoring System (Professional Use) is not intended for use in patients who are transitioning from heparin treatment to warfarin therapy.
Alere San Diego, Inc.
9975 Summers Ridge Rd.
San Diego, California 92121-2997
Reason for Recall:
Alere San Diego received 9 reports of malfunctions; 6 injuries and 3 three deaths caused by bleeding. The firm is recalling the Alere INRatio2 PT/INR Professional Test Strips due to complaints of patients who had a therapeutic or near-therapeutic INR result with the Alere INRatio2 PT/INR Professional Test Strip but a significantly higher INR result (outside of therapeutic range) when re-testing was performed by a central laboratory because of deterioration in the patient’s clinical condition.
Use of this affected product may cause serious adverse health consequences, including death.
Customers with questions about this recall or requiring product replacement can contact Alere at 1-844-292-5373 Monday through Friday, 8 am to 5 pm, Pacific Time; 11 am to 2 pm, Eastern Time. For additional information about the recall, customers should go to www.inr-care.com.
FDA District: Los Angeles District Office
More Information about this Recall:
On April 17, 2014, Alere sent an Urgent Medical Device Recall letter to all affected customers by fax, email or direct mail. The letter identified the product, problem and the actions to be taken.
Customers were requested to complete and sign a Reply Form that was included with the letter. Alere requested the completed form be sent by fax or by email.
Alere provided the following instructions for customers:
- Immediately STOP using the Alere INRatio2 PT/INR Professional Test Strips.
- Use an alternative method to perform PT/INR testing such as a plasma-based laboratory INR test, an alternative Alere product, or an alternative point-of-care monitoring system from a different manufacturer.
- Return all unused product to Alere. Alere will provide a label to return the product free of charge. This label will include a Return Goods Authorization number (RGA#). Use this label when returning the product to Alere. Your account will be credited once Alere receives the product back with the RGA#.
- Indicate the amount of unused product that will be returned for credit on the Reply Form.
- Indicate on the Reply Form which method Alere should send the Return Goods Authorization number (RGA#). You can choose to receive a RGA # from Alere by e-mail, FAX, or mail. Contact Alere Customer Service at 1-877-866-5309 for any questions regarding the product return process.
- If you have forwarded the product to another customer, please provide a copy of the recall letter to them.
- Complete and FAX or e-mail the Reply Form within 10 days to confirm your receipt of this notice. If you have questions regarding this notification, please contact Alere Technical Service by phone at 1-844-292-5373 or by E-mail at INRatio.Notification@alere.com.
About Class I Recalls:
Class I recalls are the most serious type of recall and involve situations in which there is a reasonable probability that use of these products will cause serious adverse health consequences or death.
Health care professionals and consumers may report adverse reactions or quality problems they experienced using these products to MedWatch: The FDA Safety Information and Adverse Event Reporting Program either online, by regular mail or by FAX.