Alere Cholestech LDX ALT AST Test Cassette, Model #12-788. For the in vitro quantitative determination of alanine aminotransferase (ALT) and aspartate aminotransferase (AST).
Class I - DangerousWhat Should You Do?
- Check if you have this product: Lot/Unit Codes: 274351A, 274351B, 274352B, 274353A, 290243A, 290244A, 290641A, 290641B, 290642A, 290643A, 290643B, 290644A, 290644B, 290645A, 290645B, 290646A, 290647A, 290648A, 293669A, 293670A, 293671A, 293672A, 293673A, 296635A, 296636A, 296637A, 296638A, 296639A, 296639B, 296640A, 296641A, 296642A, 297311B, 297313A, 297313B.
- 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 recall was initiated because Alere San Diego has an update for the Alere Cholestech LDX ALT AST cassette, and it has the potential for humidity changes to impact results for certain analytes on the Alere Cholestech LDX System.
- 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 ALT AST Test Cassette, Model #12-788. For the in vitro quantitative determination of alanine aminotransferase (ALT) and aspartate aminotransferase (AST).
Product Codes/Lot Numbers:
Lot/Unit Codes: 274351A, 274351B, 274352B, 274353A, 290243A, 290244A, 290641A, 290641B, 290642A, 290643A, 290643B, 290644A, 290644B, 290645A, 290645B, 290646A, 290647A, 290648A, 293669A, 293670A, 293671A, 293672A, 293673A, 296635A, 296636A, 296637A, 296638A, 296639A, 296639B, 296640A, 296641A, 296642A, 297311B, 297313A, 297313B.
Official Source
Always verify recall information with the official FDA source:
View on FDA.govFDA Recall Number: Z-1139-2013
Related Recalls
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.
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).
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.