Recall Z-2475-2019 ยท JJE Analyzer, Chemistry (Photometric, Discrete), For Clinical Use
Alere San Diego, Inc.
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) cholest
| Date | Feb 15, 2019 |
| Status | Terminated |
| Reason | 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. |
| Root cause | 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. |
| Quantity | 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 |
| FDA record | Open on fda.gov |
510(k) clearances named in this recall
| K120615 | ALERE CHOLESTECH LDX ANALYZER, ALERE CHOLESTECH LDX LIPID PROFILE - GLU CASSETTE Alere San Diego Inc. Dba Biosite,Innovacon,Hemosen, May 15, 2013 |