Alere San Diego, Inc. 2022-08-17 Health serious FDA
Health · FDA · Recall #FDA-Z-1508-2022
The Cholestech LDX¿ System combines enzymatic methodology and solidphase technology to… Recall
Issued August 17, 2022 · Alere San Diego, Inc.
In August 2022, Alere San Diego, Inc. recalled the The Cholestech LDX¿ System combines enzymatic methodology and solidphase technology to…, a serious health recall reported by the FDA.
Compiled by Maya Ellison, RecallCheckr
What this means for you
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).
What you should do
- 1 Stop using The Cholestech LDX¿ System combines enzymatic methodology and solidphase technology to… right away.
- 2 Set it aside where it won't be used by mistake.
- 3 Contact Alere San Diego, Inc. to arrange your voluntary. See the official notice below for contact details.
- 4 Keep the product until your remedy is fully processed. You may need it.
Official remedy (Voluntary):
Recall details
- Brand
- Alere San Diego, Inc.
- Category
- Health
- Recall date
- August 17, 2022
- Units affected
- Not reported
- Sold at
- 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,
- Recall number
- FDA-Z-1508-2022
- Made in
- United States
- Issuing agency
- FDA
In context
- Alere San Diego, Inc. has 2 recalls in our database.
- We're tracking 3,576 Health recalls in our database.
- This is the 870th Health recall we've logged in 2022.