Z-1546-2014Class I

Alere INRatio2 PT/INR Professional Test Strips, Model Number: 99008G2. The Alere INRatio2 PT/INR Monitoring...

Name: Z-1546-2014 Alere INRatio2 PT/INR Professional Test Strips, Model Number: 99008G2. The Alere INRatio2 PT/INR Monitoring...
Creator: Alere San Diego, Inc.
Published: 2014-04-16
License: https://open.fda.gov/license/

Alere San Diego, Inc. / initiated 2014-04-16 / Terminated

FDA source

Alere San Diego, Inc. began a recall of Alere INRatio2 PT/INR Professional Test Strips, Model Number: 99008G2. The Alere INRatio2 PT/INR Monitoring System (Professional Use), consisting of the... on 2014-04-16. FDA classified it as Class I and gives the reason as "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...". As of 2026-09-10, the recall status on record is Terminated.

Recall record

Recall number: Z-1546-2014
Classification: Class I
Status: Terminated
Initiated: 2014-04-16
Posted: 2014-05-08
Terminated: 2017-07-19
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).
Product code: GJS Test, Time, Prothrombin
Reason for recall: 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.
FDA 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 [email protected]. 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 in commerce: Estimated 99,795 Total units
Distribution: US Nationwide Distribution
Product codes and lots: 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

Enforcement reports

One row per recalled product line

FDA enforcement reports joined to recall event Z-1546-2014
Recall number	Class	Status	Voluntary or mandated	Report date	Classified
Z-1546-2014	Class I	Terminated	Voluntary: Firm initiated	2014-05-14	2014-05-08

Product code GJS

K092987Class IIInratio/inratio2 Test StripsBiosite Incorporated / cleared 2010-06-11

MDM coverage of this record lists here, newest first.

About this record

Sourced from the FDA device recall database and the FDA enforcement reports, both ingested from openFDA. The recall record supplies the product, the reason and the product code; the enforcement report supplies the classification. The two datasets are exported by FDA on different days, and the date above is the older of the two, so nothing on this page is newer than it says.

MDM adds the root cause tag, derived from FDA’s own root cause text, and the cross-links to the product code, the clearances named on the record and MDM coverage. Where a recall has not been joined to an enforcement report, no classification is shown.

Data as of 2026-10-14, the FDA export date for this dataset. Page last changed 2026-09-05. View this recall on fda.gov (opens on fda.gov)