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U.S. Department of Health and Human Services

Class 3 Device Recall Alere Cholestech LDX Analyzer and Alere Cholestech Lipid Profile

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  Class 3 Device Recall Alere Cholestech LDX Analyzer and Alere Cholestech Lipid Profile see related information
Date Initiated by Firm August 02, 2016
Create Date September 10, 2016
Recall Status1 Terminated 3 on October 28, 2016
Recall Number Z-2778-2016
Recall Event ID 74940
510(K)Number K120615  
Product Classification Ldl & vldl precipitation, cholesterol via esterase-oxidase, hdl - Product Code LBS
Product LDX Optical Check Cassettes (OCC)
Model Number: 10-228 and 14-535

Cassette in box with foam insert. The cassette is used to check the optics system of the LDX analyzer.

Product Usage:
The Optics Check Cassette is used to check the optics system of the Alere Cholestech LDX¿ Analyzer. It is run once a day before patient samples are tested and after the analyzer has been moved or serviced.
Code Information Model Number: 10-228 and 14-535 Lot Number: 332994
Recalling Firm/
Manufacturer		 Alere San Diego, Inc.
9975 Summers Ridge Rd
San Diego CA 92121-2997
For Additional Information Contact
858-805-2000 Ext. 3015
Manufacturer Reason
for Recall		 Incorrect expiration date on the magnetic strip that does not match the labeled expiration date.
FDA Determined
Cause 2		 Packaging
Action Alere issued a recall notification to customers via telephone and email. Customers was informed of the affected product, problem and actions to be taken. Customers were instructed if they have the affected lot contact the Alere technical service department at 877-308-8289 to report this lot and receive a free replacement. For questions call 877-308-8289 and reference their specific case number.
Quantity in Commerce 12,951
Distribution Worldwide Distribution - U.S Nationwide in the states of: TN, MA, GA, OK, VA, FL, TN, MO, AL, TX, IL, NY, VT, RI, KY, WI, AL, NC, LA, SD, TX, VA, MI, MN, IN, IA, CA, AR, PA, HI, WV, KS, CO, CT, UT and the countries of Japan, England, Canada
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 For details about termination of a recall see Code of Federal Regulations (CFR) Title 21 §7.55.
510(K) Database 510(K)s with Product Code = LBS and Original Applicant = ALERE SAN DIEGO INC. DBA BIOSITE,INNOVACON,HEMOSEN
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