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.
FDA Recall Z-2475-2019 · Posted None
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Recalling FirmAlere San Diego, Inc.
Recall StatusTerminated
Product CodeJJE
Date Initiated2019-02-15
Date Terminated2023-12-12
Product Quantity186 analyzer kits
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.
Firm 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 [email protected].
If you have questions, please contact Alere San Diego, Inc at 1-877-308-8289
Root Cause
Employee error
Distribution Pattern
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
Related FDA 510(k) Records
Devices referenced by this recall via K-numbers.
Official Source
View FDA Recall →Source: FDA Enforcement Report / Recall database. Always confirm against the official FDA record.
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