San Diego, CA, United States
Alere San Diego, Inc. recalls
5 recalls recorded since 2018, most recently on 20 August 2026. 3 are listed as ongoing. Status and classification are as published by the FDA.
Recalls5
Ongoing (FDA)3
Terminated or completed2
Class I (FDA)0
Ongoing Class II Medical devices
- Recall started
- 20 August 2026
- Reason
- hCG rapid tests may detect low levels of hCG below the stated assay sensitivity, which may result in false positive result.
- Distribution
- Worldwide - US Nationwide distribution including in the states of IL, PA, FL, GA, VA, NY, TN, AZ, ID, ND, WI, AL, LA, NJ,MT, NE, OH, PR, IN, MI, WY, MA, CA, TX, HI, KS, KY, AR, CO, NC, WA, IA, MN, OK, OR, NM, SC, GU, MD, NV, MS, WV, SD, VT, DE and the countries of United Kingdom, Canada, Italy, Irel
- Initiated
- Voluntary: Firm initiated
- Recall numbers
- Z-3272-2026, Z-3274-2026, Z-3271-2026, Z-3273-2026
- Fisher Scientific Sure-Vue Serum/Urine hCG, Model/ Part: FHC-202/23900529, FHC-202/23900528; Beckman Coulter Inc's ICON 25 hCG, Model/ Part: FHC-202/43025; Henry Schein One Step+ hCG Combo test in Serum or Urine, M
- Fisher Scientific Sure-Vue Urine hCG, Model/ Part: FHC-102/23900526; Henry Schein, Inc. One Step + Urine Cassette Test, Model/ Part: FHC-102/9004074, FHC-102/9004073; Alere hCG Cassette (25mIU/mL) in Urine, Model/ Part
- McKesson CONSULT hCG Urine Cassette, Model/ Part: FHC-A102/5001; Alere hCG Cassette (20 mIU/mL) in Urine, Model/ Part: FHC-A102/92210; Fisher Scientific Sure-Vue Serum/Urine¿hCG-STAT, Model/ Part: FHC-A202/23900531, F
- Fisher Scientific Sure-Vue Urine hCG Strip, Model/ Part: FHC-101/23900527; McKesson CONSULT hCG Urine Test Dipstick CLIA Waived, Model/ Part:FHC-101/5000; Henry Schein One Step+ hCG Urine Strip Test, Model/ Part: FHC-1
Ongoing Class II Medical devices
- Recall started
- 1 March 2024
- Reason
- 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.
- Distribution
- Worldwide distribution - US Nationwide and the countries of United Kingdom, Netherlands and Kenya.
- Initiated
- Voluntary: Firm initiated
- Recall number
- Z-1702-2024
- Abbott Cholestech LDX Battery Kit, Model: 3LP656194-PCM-LD, PN: 55170
Ongoing Class II Medical devices
- Recall started
- 24 June 2022
- Reason
- 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).
- Distribution
- US: IL, NV, FL, LA, CA, MA, MN, NC, AK, NE, TX, PA, RI, SC, TN, OK, KY, GA, NY, MO, CO, AZ, OH, HI, VA, KS, IN, AL. OUS: GB, ZA, NO, NL, FI, IE, IQ, IT, CH, DE, ES, HU, SI, NA, PT, IS, NG, PL, CY, TN, BH, ID, MY, AU, SG, JP, IN, BD, KR, HK, BR, CO, AR, CA
- Initiated
- Voluntary: Firm initiated
- Recall number
- Z-1508-2022
- 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 fingersti
Terminated Class II Medical devices
- Recall started
- 15 February 2019
- Terminated
- 12 December 2023
- 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.
- 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
- Initiated
- Voluntary: Firm initiated
- Recall number
- Z-2475-2019
- 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 syste
Completed Class II Medical devices
- Recall started
- 14 November 2017
- Reason
- The recalled lots have demonstrated unexpected false positive THC results.
- Distribution
- Worldwide distribution - United States Nationwide and the countries of Japan, Canada
- Initiated
- Voluntary: Firm initiated
- Recall number
- Z-0418-2018
- 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
A terminated FDA recall means the FDA has determined that all reasonable efforts to remove or correct the product have been made. What statuses mean.