FDA Medical Device Recalls (openFDA)
Alere San Diego, Inc.: Alere INRatio2 PT/INR Professional Test Strips, Model Number: 99008G2. The Alere INRatio2 PT/INR Monitoring System (Professional Use), consisting of the Monitor and test strip, is used for quantitative determination of international normalized ratio (INR) in fresh, capillary whole blood to monitor the effect of warfarin therapy on clotting time by health care professionals. (in vitro diagnostic use).
- Recall number
- Z-1546-2014
- Recalling firm
- Alere San Diego, Inc.
- Product
- Alere INRatio2 PT/INR Professional Test Strips, Model Number: 99008G2. The Alere INRatio2 PT/INR Monitoring System (Professional Use), consisting of the Monitor and test strip, is used for quantitative determination of international normalized ratio (INR) in fresh, capillary whole blood to monitor the effect of warfarin therapy on clotting time by health care professionals. (in vitro diagnostic use).
- Status
- Terminated
- Initiated
- 2014-04-16
- Posted
- 2014-05-08
- Terminated
- 2017-07-19
- Reason
- 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.
- Root cause
- Under Investigation by firm
- Action
- Alere sent an Urgent: Medical Device Recall letter dated April 16, 2014 via fax, email or direct mail. The letter identified the affected product, problem and actions to be taken. Customers were instructed to discontinue use, return remaining inventory to Alere, and complete the provided verification form to acknowledge receipt of the recall notice. For questions contact Alere Technical Service by phone at 844-292-5373 or by E-mail at INRatio.Notification@alere.com. UPDATED: On 05/06/2014, Alere issued a press release on this recall to the consumer/public level. The press release, dated May 6, 2014, announced Alere Inc.s voluntary Class I recall in the U.S. of the Alere INRatio2 PT/INR Professional Test Strips (PN 99008G2). The press release also stated the following information: reason for recall, any adverse event reports, reason for the adverse event reports , root cause not yet determined, notified customers to immediately STOP using the product, product description with codes, contact information, FDA MedWatch information and about Alere and About the Alere INRation2 PT/INR Professional Monitoring System.
- Quantity
- Estimated 99,795 Total units
- Distribution
- US Nationwide Distribution
- Lot, serial or model codes
- 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
- 510(k) numbers
- ["K092987"]
- PMA numbers
- not on file
- Product code
- GJS
- Firm FEI
- 1000125596
- Firm city
- San Diego
- Firm state
- CA
- Firm country
- not on file
Where this comes from
- Register
- FDA Medical Device Recalls (openFDA)
- Publisher
- U.S. Food and Drug Administration (openFDA)
- File
- device-recall-0001-of-0001.json.zip
- sha256
- b87518bfe2e8
- Size
- 288210821 bytes
- Published
- 2026-09-28
- Read
- 2026-09-29T08:25:23.626Z
- Source file
- Source file retained · verify
- Refresh due
- 2026-10-06
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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