Recall Z-1139-2013— Alere San Diego, Inc.
Class II · Terminated
Class II FDA medical device recall by Alere San Diego, Inc., initiated 2013-03-06, terminated 2013-08-13. It names 2 FDA 510(k) clearances: K032027, K991834. Product: 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: 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..
- Recalling firm
- Alere San Diego, Inc.
- Classification
- Class II
- Status
- Terminated
- Initiated
- 2013-03-06
- Terminated
- 2013-08-13
- Firm location
- San Diego, CA, United States
510(k) clearances named in this recall
2 on FDA's record- K032027 — CHOLESTECH LDX ASPARTATE AMINOTRANSFERASE (AST)
- K991834 — CHOLESTECH LDX ALANINE AMINOTRANSFERASE (ALT), MODEL 11-772
K-numbers as listed on FDA's Recall Enterprise System record for this event (openFDA device/recall k_numbers). The recall may also cover devices cleared under other submissions not named here.
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.
Data sourced from openFDA. This site is unofficial and independent of the FDA.