Z-2661-2011

0200086, Triad Alcohol Prep Pads, 100 box 0200432, Alcohol Prep Pads, packaged in the Alere INRatio 2 PT/INR...

Name: Z-2661-2011 0200086, Triad Alcohol Prep Pads, 100 box 0200432, Alcohol Prep Pads, packaged in the Alere INRatio 2 PT/INR...
Creator: Alere San Diego
Published: 2011-02-28
License: https://open.fda.gov/license/

Alere San Diego, Inc. / initiated 2011-02-28 / Terminated

FDA source

Alere San Diego began a recall of 0200086, Triad Alcohol Prep Pads, 100 box 0200432, Alcohol Prep Pads, packaged in the Alere INRatio 2 PT/INR Home Monitoring Kit; or Hemosense INRatio 2... on 2011-02-28. The reason FDA records is "The recall of the Triad Group alcohol prep products is due to potential contamination of these products with the bacteria Bacillus cereus, which could lead to life-threatening infections". As of 2026-09-10, the recall status on record is Terminated.

Recall record

Recall number: Z-2661-2011
Status: Terminated
Initiated: 2011-02-28
Posted: 2011-06-24
Terminated: 2012-02-29
Recalling firm: Alere San Diego, Inc.
Product: 0200086, Triad Alcohol Prep Pads, 100 box 0200432, Alcohol Prep Pads, packaged in the Alere INRatio 2 PT/INR Home Monitoring Kit; or Hemosense INRatio 2 Prothrombin Time/lNR Testing Kit, Self-Test System; 0100007, Alcohol Prep Pads, packaged in the Hemosense INRatio Prothrombinme/lNR Testing Kit, Self- Test System; 0100072, Alcohol Prep Pads, packaged in the INRatio Starter Kit
Product code: GJS Test, Time, Prothrombin
Reason for recall: The recall of the Triad Group alcohol prep products is due to potential contamination of these products with the bacteria Bacillus cereus, which could lead to life-threatening infections.
FDA root cause: Other
Action: Alere sent a CUSTOMER NOTIFICATION letter on February 28, 2011 to all affected custumers. The letter included; description of product, affected lots, statement of potential for contamination which could lead to life-threatening infections. Alere asked its customers to discard the Triad Alcohol Prep Pads provided and complete and FAX the enclosed Verification Form within 10 days to confirm receipt of notice and to indicate the number of discarded/required replacement alcohol prep pads. The letter instructed customers to call Alere Technical Services for additional information at 888-246-7483.
Quantity in commerce: Estimated 4829 total units
Distribution: Worldwide Distribution--(USA) Nationwide and countries of Canada, Australia, Japan and Puerto Rico
Product codes and lots: Lot/Unit Codes: Applicable to all INRatio kit lots packaged Triad Alcohol prep pads from 4/19/09 through 2/7/11, including the following: 218494,220447,223941,223943,224250,224251,224770,224771,224772,225544,229364,229365, 229366,229367,229368,229369,229370,229371,235188,235189,236334,236335,236336,238868, 238869,239283,239418,239419,239595,243020,243021,243413,243414,243415,243416,243417, 243418,243855,243856,243857,243858,243859,243860,243861,243862,243863,243864,243865, 244432,245759,245760,245761,245762,245763,245764

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 2026-10-07, the FDA export date for this dataset. Page last changed 2026-09-05. View this recall on fda.gov (opens on fda.gov)