Alere San Diego, Inc.: Medical Device Recall in 2019 - (Recall #: Z-2475-2019)

Updated on March 25, 2026.

See the recall detail below. You can also see other recalls from the same firm in 2019.

Data Source: FDA.

Product Description:

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.

Product Classification:

Class II

Date Initiated: February 15, 2019

Date Posted: September 11, 2019

Recall Number: Z-2475-2019

Event ID: 83410

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.

Status: Terminated

Product Quantity: 186 analyzer kits

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

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

Voluntary or Mandated:

Voluntary: Firm initiated