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U.S. Department of Health and Human Services

Class 2 Device Recall Alere Cholestech LDX Analyzer

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  Class 2 Device Recall Alere Cholestech LDX Analyzer see related information
Date Initiated by Firm February 15, 2019
Create Date September 05, 2019
Recall Status1 Terminated 3 on December 12, 2023
Recall Number Z-2475-2019
Recall Event ID 83410
510(K)Number K120615  
Product Classification Analyzer, chemistry (photometric, discrete), for clinical use - Product Code JJE
Product Alere Cholestech LDX Analyzer, model # 14-874 containing power supplies with the identifying codes of 1837d and 1843d - Product Usage: The Alere Cholestech LDX System is a small, portable analyzer and test cassette system. The System is for in vitro diagnostic use only. The Lipid Profile GLU Cassette is for the quantitative determination of total cholesterol, HDL (high-density lipoprotein) cholesterol, triglycerides and glucose in whole blood. A TC/HDL (total cholesterol/HDL cholesterol) ratio and estimated values for LDL (low-density lipoprotein) and non-HDL cholesterol are calculated by the Alere Cholestech LDX¿ Analyzer.
Code Information Lot/Unit Codes: Lot codes of Meter Kits: 418197, 418198, 418199, 418252, & 418253 Lot codes of Power Supplies: 724599, 724604, & 725914  Serial Numbers: AA184455, AA184344, AA184328, AA184388, AA184304, AA184349, AA184396, AA184339, AA184421, AA184280, AA184435, AA184427, AA184395, AA183401, AA184394, AA184710, AA184345, AA184039, AA184463, AA184609, AA184383, AA184415, AA184094, AA184070, AA184412, AA183861, AA184278, AA184283, AA184711, AA184392, AA184343, AA184368, AA184708, AA184350, AA184674, AA184378, AA184433, AA184366, AA184365, AA184354, AA184369, AA184067, AA184353, AA184664, AA184279, AA184355, AA184270, AA184285, AA184017, AA184272, AA184340, AA184346, AA184347, AA184336, AA184342, AA184269, AA184376, AA184949, AA184386, AA184351, AA184341, AA184413, AA184298, AA183707, AA184595, AA184364, AA184287, AA184618, AA184971, AA184334, AA184845, AA184267, AA184296, AA184333, AA184608, AA184651, AA184319, AA184348, AA184317, AA184699, AA184430, AA184432, AA184363, AA184030, AA184338, AA184371, AA184375, AA184393, AA184306, AA184447, AA183418, AA184323, AA184401, AA184438, AA184594, AA184281, AA184461, AA184312, AA184321, AA184288, AA184357, AA184380, AA184617, AA184352, AA184273, AA184303, AA184424, AA184290, AA184300, AA184916, AA184965, AA184963, AA184980, AA184964, AA184955, AA185069, AA185009, AA184904, AA184993, AA184973, AA184991, AA184995, AA184900, AA185046, AA184951, AA185927, AA184468, AA185050, AA184967, AA184853, AA184877, AA184830, AA184961, AA184794, AA184930, AA184459, AA184887, AA184869, AA185020, AA184785, AA184985, AA184901, AA184979, AA184990, AA184865, AA184988, AA184872, AA184952, AA184946, AA184924, AA182949, AA184918, AA184928, AA184886, AA184957, AA184974, AA184862, AA185022, AA184657, AA184880, AA185021, AA184922, AA184875, AA185013, AA184943, AA184873, AA184989, AA184742, AA184876, AA184301, AA184367, AA184370, AA184359, AA184434, AA184615, AA185004, AA184678, AA184329, AA184377, AA184326, AA184284, AA184384, AA184795, AA184297, AA183549, AA184318
Recalling Firm/
Manufacturer		 Alere San Diego, Inc.
9975 Summers Ridge Rd
San Diego CA 92121-2997
For Additional Information Contact Carmen Bergelin
858-805-2000 Ext. 3015
Manufacturer Reason
for Recall		 The polarity of the output of power supply was reversed. Due to polarity of the output of power supplies being reversed, it renders the power supplies nonfunctional and the analyzer inoperable.
FDA Determined
Cause 2		 Employee error
Action On 2/15/2019, the firm provided a urgent medical device recall letter to all consignees who received the affected product. The letter was provided in a combination of methods to those consignees via direct mail, email or fax. The letter informed consignees of the following: 1. Alere San Diego, Inc. has concurrently sent a replacement Alere Cholestech LDX¿ Power Supply at no extra cost to your shipping address on record via FedEx. Please refer to Purchase Order Number ASD119LDX for the replacement shipment. 2. " Discontinue use of and discard the affected Alere Cholestech LDX¿ Power Supply. 3. If you have forwarded the product listed above to another facility, please provide a copy of this letter to them. 4. Complete and FAX or email the enclosed Verification Form within 10 days to confirm your receipt of this notice. 5. If you need to report any concerns you may have about the performance of the Alere Cholestech LDX¿ System, please contact Technical Services at 1-877-308-8289 or by email at LDX.Support@alere.com. If you have questions, please contact Alere San Diego, Inc at 1-877-308-8289
Quantity in Commerce 186 analyzer kits
Distribution US Nationwide distribution in the states of AK, A, AZ, CA, CO, CT, FL, GA, HI, IA, IL, IN, KS, KY, LA, MA, MD, MI, MN, MO, MS, MT, NC, ND, NH, NJ, NM, NY< OH, OR, PA, RI, SC, SD, TN, TX, VA, VT, WA, WI. No OUS consignees
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 = JJE and Original Applicant = ALERE SAN DIEGO INC. DBA BIOSITE,INNOVACON,HEMOSEN
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