Recall Z-0559-2012 ยท LCP Assay, Glycosylated Hemoglobin
Heritage Labs International LLC
Heritage Labs Appraise Diabetes A1c Test , 12 kits/shipping carton (Product K7602), each kit packed in a box and contains 1 Triad Medium Alcohol Prep Pad, Cat. No. 10-3001, NDC 50730-3001-0, and blood specimen collection supplies, forms, and instructions. Blood specimen collection
| Date | Jan 11, 2012 (initiated Jan 9, 2011) |
| Status | Terminated |
| Reason | Kits contain recalled Triad alcohol pads |
| Root cause | Material/Component Contamination |
| Action | Heritage Labs sent a Device Notification and Safety Alert letter dated January 12, 2011, to all affected customers. The letter identified the product, the problem, and the action to be taken by the customer. Heritage Labs sent replacement alcohol prep pads from a different supplier not affected by the recall to user of Heritage Labs kits. Heritage Labs recommended the replacements be on "as needed" basis. Upon opening kit, users should immediately dispose of sealed TRIAD brand alcohol pads. Users are to use the replacement wipes instead of the wipes contained in the kits. For any ques |
| Quantity | 252 kits |
| Distribution | Worldwide Distribution - USA (nationwide) and Germany |
| FDA record | Open on fda.gov |
510(k) clearances named in this recall
| K990899 | HEMOCHEK-A1C SAMPLE COLLECTION KIT Osborn Group, Inc., Dec 21, 1999 |