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U.S. Department of Health and Human Services

Class 2 Device Recall Cholestech LDX Battery Kit

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  Class 2 Device Recall Cholestech LDX Battery Kit see related information
Date Initiated by Firm March 01, 2024
Date Posted April 30, 2024
Recall Status1 Open3, Classified
Recall Number Z-1702-2024
Recall Event ID 94190
510(K)Number K120615  
Product Classification Glucose oxidase, glucose - Product Code CGA
Product Abbott Cholestech LDX Battery Kit, Model: 3LP656194-PCM-LD, PN: 55170
Code Information All Lots/ UDI:
Recalling Firm/
Manufacturer		 Alere San Diego, Inc.
9975 Summers Ridge Rd
San Diego CA 92121-2997
For Additional Information Contact Customer Service
877-308-8289 Ext. 3015
Manufacturer 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.
FDA Determined
Cause 2		 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 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.
Quantity in Commerce 559 units
Distribution Worldwide distribution - US Nationwide and the countries of United Kingdom, Netherlands and Kenya.
Total Product Life Cycle TPLC Device Report
1 A record in this database is created when a firm initiates a correction or removal action. The record is updated if the FDA identifies a violation and classifies the action as a recall, and it is updated for a final time when the recall is terminated. Learn more about medical device recalls.
2 Per FDA policy, recall cause determinations are subject to modification up to the point of termination of the recall.
3 The manufacturer has initiated the recall and not all products have been corrected or removed. This record will be updated as the status changes.
510(K) Database 510(K)s with Product Code = CGA and Original Applicant = ALERE SAN DIEGO INC. DBA BIOSITE,INNOVACON,HEMOSEN
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