Device 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.
Z-2475-2019
Product summary
- Event
- Event 83410
- Status
- Terminated
- Classification
- Class II
- Quantity
- 186 analyzer kits
- Official record key
device-enforcement:Z-2475-2019
Official wording
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.
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
Derived failure modes
-
Unknown
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.