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
FDA Recall Z-2661-2011 · Posted 2011-06-24
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Recalling FirmAlere San Diego
Recall StatusTerminated
Product CodeGJS
Date Initiated2011-02-28
Date Terminated2012-02-29
Product QuantityEstimated 4829 total units
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.
Firm 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.
Root Cause
Other
Distribution Pattern
Worldwide Distribution--(USA) Nationwide and countries of Canada, Australia, Japan and Puerto Rico
Related FDA 510(k) Records
Devices referenced by this recall via K-numbers.
Official Source
View FDA Recall →Source: FDA Enforcement Report / Recall database. Always confirm against the official FDA record.
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