Recall Z-1702-2024 ยท CGA Glucose Oxidase, Glucose
Alere San Diego, Inc.
Abbott Cholestech LDX Battery Kit, Model: 3LP656194-PCM-LD, PN: 55170
| Date | Apr 30, 2024 (initiated Mar 1, 2024) |
| Status | Open, Classified |
| Reason | There is a potential that the Cholestech LDX battery (an external battery pack available as an optional accessory to the Cholestech LDX Analyzer) may swell which could cause minor burns, cuts or abrasions, or low current electrical shock to the user. |
| Root cause | Labeling design |
| Action | On March 28, 2024, Alere San Diego issued a Urgent Medical Device Correction notification to affected consignees via mail. In addition to informing consignees about the recall, Alere asked consignees to take the following actions: " Inspect all Cholestech LDX" Battery Kits for any signs of swelling. DO NOT CONTINUE USE OF BATTERIES THAT APPEAR SWOLLEN. If your battery pack exhibits any signs of swelling, the product should not be used and discarded per local regulations. " If the battery appears normal, then it can continue to be used. " Complete and return the Customer Reply Form. " If yo |
| Quantity | 559 units |
| Distribution | Worldwide distribution - US Nationwide and the countries of United Kingdom, Netherlands and Kenya. |
| FDA record | Open on fda.gov |
510(k) clearances named in this recall
| K120615 | ALERE CHOLESTECH LDX ANALYZER, ALERE CHOLESTECH LDX LIPID PROFILE - GLU CASSETTE Alere San Diego Inc. Dba Biosite,Innovacon,Hemosen, May 15, 2013 |