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.

Class I - Dangerous

🏥 Medical Devices Recalled: February 15, 2019 Alere San Diego Diagnostic Equipment Nationwide

What Should You Do?

Check if you have this product:
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
Do not eat it: Even if it looks and smells fine, do not consume this product.
Throw it away or return it: You can return the product to the store for a full refund.
Seek medical attention if needed: If you've consumed this product and feel unwell, contact your doctor immediately.
Report problems: Report any issues to the FDA's Safety Reporting Portal.

⚠️ Emergency: If you experience severe symptoms after consuming this product, call 911 or Poison Control at 1-800-222-1222.

Recall Details

Company:: Alere San Diego, Inc.
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.
Classification:: Class I - Dangerous
Dangerous or defective products that predictably could cause serious health problems or death.
Status:: terminated

Product Information

Full 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 Codes/Lot Numbers:

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

Official Source

Always verify recall information with the official FDA source:

View on FDA.gov

FDA Recall Number: Z-2475-2019

Related Recalls

Abbott Cholestech LDX Battery Kit, Model: 3LP656194-PCM-LD, PN: 55170

Alere San Diego

Class I - Dangerous

There is a potential that the Cholestech LDX battery (an external battery pack available as an optional accessory to the Cholestech LDX Analyzer) may swell which could cause minor burns, cuts or abrasions, or low current electrical shock to the user.

Mar 1, 2024 Other Medical Devices Nationwide View Details →

The Cholestech LDX¿ System combines enzymatic methodology and solidphase technology to measure total cholesterol, HDL cholesterol, triglycerides and glucose. Samples used for testing can be whole blood from a fingerstick (collected in a lithium heparin-coated capillary tube) or venipuncture. The sample is applied to an Cholestech LDX¿ cassette. Description/Part: Cholestech LDX Lipid Profile GLU Cassette/10-991, 99021, 14-531; Cholestech LDX TC HDL GLU Cassette/10-990; Cholestech LDX Lipid Profile Cassette/10-989; Cholestech LDX TC HDL Cassette/10-987

Alere San Diego

Class I - Dangerous

Cholesterol test cassettes package insert is to be updated with new bilirubin interference information because it was found that samples containing bilirubin, at concentrations greater than 2.0 mg/dL (conjugated) or 1.6 mg/dL (unconjugated), can result in low recovery of Triglyceride (TRG) and High-Density Lipoproteins (HDL).

Jun 24, 2022 Diagnostic Equipment Nationwide View Details →

Triage Drugs of Abuse Plus TCA 25 Test Kit, Model Numbers 92000, 92590, 92591; 25 individually pouched devices, 1 bottle of Wash Solution, 1 Pipette and 50 Pipette Tips in a labeled kit box. Product Usage: The Alere Triage Drugs of Abuse Panel plus Tricyclic Antidepressants uses eight discrete competitive immunoassay procedures for the simultaneous detection and identification of the major drugs and/or the urinary metabolites of eight different drug classes. The use of monoclonal antibodies that are specific for the drugs and/or metabolites of the eight drug classes ensures a high degree of sensitivity and specificity.

Alere San Diego

Class I - Dangerous

The recalled lots have demonstrated unexpected false positive THC results.

Nov 14, 2017 Diagnostic Equipment Nationwide View Details →