Alere San Diego, Inc.: INRatio Monitors - 0100004 Alere INRatio PT/INR System Professional - 0100007 INRatio Prothrombin Time (PT) Monitoring System - 0100137 Alere INRatio Replacement Monitor The test systems contain individually packaged components needed to use the product, such as a monitor, user guide, quick reference guide training DVD or CD, Lancets (home monitoring kits contain an Autolet, Unilet, gauze pads, and alcohol wipes), power supply (home monitoring kits contain AA batteries), results log book and a warranty card. None of the components, except for the lancets, are sterile. In vitro diagnostic monitoring system used for the quantitative measurement of Prothrombin Time (PT) in fresh, capillary whole blood.

Recall number

Z-0881-2015

Recalling firm

Alere San Diego, Inc.

Product

INRatio Monitors - 0100004 Alere INRatio PT/INR System Professional - 0100007 INRatio Prothrombin Time (PT) Monitoring System - 0100137 Alere INRatio Replacement Monitor The test systems contain individually packaged components needed to use the product, such as a monitor, user guide, quick reference guide training DVD or CD, Lancets (home monitoring kits contain an Autolet, Unilet, gauze pads, and alcohol wipes), power supply (home monitoring kits contain AA batteries), results log book and a warranty card. None of the components, except for the lancets, are sterile. In vitro diagnostic monitoring system used for the quantitative measurement of Prothrombin Time (PT) in fresh, capillary whole blood.

Status

Terminated

Initiated

2014-12-05

Posted

2015-01-03

Terminated

2017-09-18

Reason

In certain cases, an INRatio PT/INR Monitor system may provide an INR result that is significantly lower than a result obtained using a reference INR system (laboratory method). This issue can arise if the patient has certain medical conditions. It can also occur if the instructions in the labeling for performing the test are not followed.

Root cause

Under Investigation by firm

Action

An Urgent: Medical Device Correction, dated December 5, 2014, was sent to Healthcare Professionals. The letter identified the affected product and reason for recall. Customers were instructed to: -Ensure they have read and understand the precautions described in the current product labeling (a complete list of product labeling is provided in Appendix A) and the additional precautions in this notice describing medical conditions that may increase the risk of obtaining a (falsely or erroneously) lower than expected INR result. The INRatio PT/INR Monitor system should NOT be used if the patient has any of the medical conditions described. -Verify that the patient has hematocrit within the range of 30% to 55%. If not, immediately transition the patient to an alternate INR monitoring method. -Perform INR verification testing for the patients using a laboratory INR test method. Immediately transition any patient with a significantly discrepant low result on the INRatio PT/INR Monitor system to an alternative INR monitoring method. -If have forwarded product to another customer, please provide a copy of this letter to them. -Please complete and FAX or e-mail the enclosed Reply Form (Appendix B the last page of this notice) within 10 days to confirm your receipt of this notice. Customers can contact Alere INRatio Recall Hotline by phone at 1-877-929-2579, for questions regarding this notification. Additionally, a website has been established providing information and frequently asked questions. www.inr-care.com Please FAX or e-mail the completed Reply Form to: Alere San Diego, Inc. Fax: 1-877-929-2580 E-mail: Alere4319@stericycle.com.

Quantity

231,967 Test Systems including Monitors

Distribution

Worldwide Distribution -- US nationwide, Canada, South America, EU, Asia Pacific, Africa, and Middle East.

Lot, serial or model codes

All lots of part numbers: 0100004, 0100007, and 0100137.

510(k) numbers

["K020679","K021923","K092987"]

PMA numbers

not on file

Product code

GJS

Firm FEI

1000125596

Firm city

San Diego

Firm state

CA

Firm country

not on file

Cite as

FDA Medical Device Recalls (openFDA) (U.S. Food and Drug Administration (openFDA)), device-recall-0001-of-0001.json.zip, sha256 b87518bfe2e8, published 2026-09-28

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