0200086, Triad Alcohol Prep Pads, 100 box 0200432, Alcohol Prep Pads, packaged in the Alere INRatio 2 PT/INR Home Monito
FDA device recall Z-2661-2011 · posted 2011-06-24 · Terminated
Recall details
- Recalling firm
- Alere San Diego
- 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.
- Action taken
- 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
- Status
- Terminated
- Product code
- GJS
- Quantity affected
- Estimated 4829 total units
- Distribution
- Worldwide Distribution--(USA) Nationwide and countries of Canada, Australia, Japan and Puerto Rico
- Date initiated
- 2011-02-28
- Date posted
- 2011-06-24
- Date terminated
- 2012-02-29
- Location
- San Diego, CA
Monitor recalls programmatically
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Related 510(k) clearances
| Record | Firm | Date |
|---|---|---|
| INRATIO/INRATIO2 TEST STRIPS (K092987) | Biosite Incorporated | 2010-06-11 |