Abbott Cholestech LDX Battery Kit, Model: 3LP656194-PCM-LD, PN: 55170
FDA device recall Z-1702-2024 · posted 2024-04-30 · Open, Classified
Recall details
- Recalling firm
- Alere San Diego, Inc.
- Reason for recall
- 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.
- Action taken
- 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 you have forwarded the products listed above to other laboratories, please inform them of this Product Correction and provide to them a copy of this letter. " Please retain this letter for your laboratory records.
- Root cause
- Labeling design
- Status
- Open, Classified
- Product code
- CGA
- Quantity affected
- 559 units
- Distribution
- Worldwide distribution - US Nationwide and the countries of United Kingdom, Netherlands and Kenya.
- Date initiated
- 2024-03-01
- Date posted
- 2024-04-30
- Location
- San Diego, CA
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Related 510(k) clearances
| Record | Firm | Date |
|---|---|---|
| ALERE CHOLESTECH LDX ANALYZER, ALERE CHOLESTECH LDX LIPID PROFILE - GLU CASSETTE (K120615) | Alere San Diego Inc. Dba Biosite,Innovacon,Hemosen | 2013-05-15 |