FDA-Device2013-04-24Class II
Alere Cholestech LDX ALT AST Test Cassette, Model #12-788. For the in vitro quantitative determination of alanine aminotransferase (ALT) and aspartate aminotransferase (AST).
Alere San Diego, Inc.
Hazard
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.
Sold states
Worldwide Distribution-USA (nationwide) and the countries of Canada, South Africa, Netherlands, Italy, Brazil, Singapore, Russia, Hong Kong, Argentina, South Korea, Philippines, El Salvador, Indonesia, and Trinidad.
Affected count
38,571 kits
Manufactured in
9975 Summers Ridge Rd, N/A, San Diego, CA, United States
Products
Alere Cholestech LDX ALT AST Test Cassette, Model #12-788. For the in vitro quantitative determination of alanine aminotransferase (ALT) and aspartate aminotransferase (AST).
Official notice
https://www.accessdata.fda.gov/scripts/ires/index.cfm?Product=Z-1139-2013Don't want to check this manually?
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