CLASS II ONGOING Device recall · Reported 17 Aug 2022 · FDA Enforcement Report
The Cholestech LDX¿ System combines enzymatic methodology recalled
Alere San Diego is recalling The Cholestech LDX¿ System combines enzymatic methodology and solidphase technology to, distributed in 31 states. The recall was initiated on 24 Jun 2022 and the FDA has classified it as Class II.
Check your package
Stop using the device if the notice says to, and contact the manufacturer or your healthcare provider for the correction or replacement.
Recall details
- Recall number
- Z-1508-2022
- FDA event ID
- 90508
- Recalling firm
- Alere San Diego, San Diego, CA
- Classification
- Class II
- Status
- Ongoing
- Recall initiated
- 24 Jun 2022
- FDA classified
- 6 Aug 2022
- Reported
- 17 Aug 2022
- Type
- Voluntary: Firm initiated
- Customers notified by
- Letter
- Reason category
- Packaging Defects
- Device type
- Insulin Pumps & Glucose Monitors
Timeline
| 24 Jun 2022 | Recall initiated by company | |
| 6 Aug 2022 | Classified by FDA | +43 days |
| 17 Aug 2022 | Published in enforcement report | +11 days |
Companies usually start a recall weeks before the FDA classifies and publishes it; the gap above is that lag.
Reason for recall
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).
Packaging recalls include wrong labels, wrong products in the wrong bottle, missing leaflets, short-filled or empty capsules and seals that fail.
Product as listed by the FDA
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
Where it was distributed
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
AlaskaAlabamaArkansasArizonaCaliforniaColoradoDelawareFloridaGeorgiaHawaiiIdahoIllinoisIndianaKansasKentuckyLouisianaMassachusettsMinnesotaMissouriNorth Carolina
Questions about this recall
Why was it recalled?
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).
Which lots are affected?
All lots of Part/UDI-DI: 10-991/00893038002654, 99021/00899722002344, 14-531/04571226470831, 10-990/00893038002647, 10-989/00893038002630, 10-987/00893038002616
Where was it sold?
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
What should I do if I have it?
Stop using the device if the notice says to, and contact the manufacturer or your healthcare provider for the correction or replacement.
What does Class II mean?
Class II means the product may cause temporary or medically reversible health problems, or the probability of serious harm is remote.
Read the official FDA notice · Source record retrieved 26 Sep 2026. The FDA describes openFDA data as unvalidated; the official notice takes precedence. This page reports the record and gives no medical advice.
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