Alere Cholestech LDX ALT AST Test Cassette, Model #12-788. For the in vitro quantitative determination of alanine aminotransferase (ALT) and aspartate aminotransferase (AST).
Reported: April 24, 2013 Initiated: March 6, 2013 #Z-1139-2013
Product 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).
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.
Details
- Recalling Firm
- Alere San Diego, Inc.
- Units Affected
- 38,571 kits
- Distribution
- 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.
- Location
- San Diego, CA
Frequently Asked Questions
What product was recalled? ▼
Alere Cholestech LDX ALT AST Test Cassette, Model #12-788. For the in vitro quantitative determination of alanine aminotransferase (ALT) and aspartate aminotransferase (AST).. Recalled by Alere San Diego, Inc.. Units affected: 38,571 kits.
Why was this product recalled? ▼
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.
Which agency issued this recall? ▼
This recall was issued by the FDA Devices on April 24, 2013. Severity: Moderate. Recall number: Z-1139-2013.
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