Alere INRatio2 PT/INR Professional Test Strips recall
Alere INRatio2 PT/INR Professional Test Strips, Model Number: 99008G2. The Alere INRatio2 PT/INR Monitoring System (Professional Use), consisting of…
Why was Alere INRatio2 PT/INR Professional Test Strips recalled?
Test Strips may report an inaccurately low INR result. Several patients had a therapeutic or near-therapeutic INR with the Alere INRatio2 PT/INR Professional Test Strip but a significantly higher INR (outside of therapeutic range) when performed by a central laboratory.
What should I do if I have this product?
Review the official FDA enforcement record for current instructions.
What to do with a recalled product: refunds, receipts, safe disposal and how to report a problem.
Is my product affected?
Compare the item in your hand with every identifier below from the official FDA record. Only products that match the listed product and lot, UPC or model codes are part of this recall.
Which lot codes, UPCs or models are affected?
Lot/Unit Codes: Applicable to all Alere INRatio2 PT/INR Professional Test Strips lots packaged from 8/22/13 through 3/28/14, including the following: 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 Expiration date, or Expected shelf life: range from 4/30/14 to 1/31/15
- Product
- Alere INRatio2 PT/INR Professional Test Strips, Model Number: 99008G2. The Alere INRatio2 PT/INR Monitoring System (Professional Use), consisting of…
- Recalling firm
- Alere San Diego, Inc.
- Quantity
- Estimated 99,795 Total units
- Distribution
- US Nationwide Distribution
- Recall date
- May 14, 2014
- Classification
- Class I
- Status
- Terminated
- Agency
- FDA (device)