Recall Z-1139-2013 ยท CKD Hydrazone Colorimetry, Alt/Sgpt
Alere San Diego, Inc.
Alere Cholestech LDX ALT AST Test Cassette, Model #12-788. For the in vitro quantitative determination of alanine aminotransferase (ALT) and aspartate aminotransferase (AST).
| Date | Apr 17, 2013 (initiated Mar 6, 2013) |
| Status | Terminated |
| Reason | The recall was initiated because Alere San Diego has an update for the Alere Cholestech LDX ALT AST cassette, and it has the potential for humidity changes to impact results for certain analytes on the Alere Cholestech LDX System. |
| Root cause | Other |
| Action | Alere sent an "URGENT MEDICAL DEVICE RECALL UPDATE" letter dated March 6, 2013 to all affected customers. The letter informed the customers of the problem identified and the actions to be taken. Customers with any questions about the recall notification, are instructed to contact Alere San Diego 9975 Summers Ridge Rd, San Diego, CA 92121; (877) 308-8289; Fax: (858) 805-8457. Customers are instructed to complete the customer response form even if they do not have any involved product. |
| Quantity | 38,571 kits |
| Distribution | Worldwide Distribution-USA (nationwide) and the countries of Canada, South Africa, Netherlands, Italy, Brazil, Singapore, Russia, Hong Kong, Argentina, South Korea, Philippines, El Salvador, Indonesia, and Trinidad. |
| FDA record | Open on fda.gov |