Alere Cholestech LDX ALT AST Test Cassette, Model #12-788. For the in vitro quantitative determination of alanine aminot
FDA device recall Z-1139-2013 · posted 2013-04-17 · Terminated
Recall details
- Recalling firm
- Alere San Diego, Inc.
- Reason for recall
- 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.
- Action taken
- 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.
- Root cause
- Other
- Status
- Terminated
- Product code
- CKD
- Quantity affected
- 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
- Date initiated
- 2013-03-06
- Date posted
- 2013-04-17
- Date terminated
- 2013-08-13
- Location
- San Diego, CA
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Related 510(k) clearances
| Record | Firm | Date |
|---|---|---|
| CHOLESTECH LDX ASPARTATE AMINOTRANSFERASE (AST) (K032027) | Cholestech Corp. | 2003-09-05 |
| CHOLESTECH LDX ALANINE AMINOTRANSFERASE (ALT), MODEL 11-772 (K991834) | Cholestech Corp. | 1999-09-09 |