FDA Device recall Z-1139-2013
Alere Cholestech LDX ALT AST Test Cassette, Model #12-788
- FDA Device
- Class II
- terminated
- Published 2013-04-24
On 2013-04-24 the FDA classified a Class II recall of Alere Cholestech LDX ALT AST Test Cassette, Model #12-788 by Alere San Diego, citing 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 c….
Read the official FDA Device notice
| Agency | FDA Device |
|---|---|
| Recall number | Z-1139-2013 |
| Classification | Class II |
| Status | terminated |
| Initiated | 2013-03-06 |
| Published | 2013-04-24 |
| Last updated | 2026-09-13 11:53 UTC |
| Company | Alere San Diego |
| Distribution | US |
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.
Identifiers
| code_info | Lot/Unit Codes: 274351A, 274351B, 274352B, 274353A, 290243A, 290244A, 290641A, 290641B, 290642A, 290643A, 290643B, 2906…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. |
|---|
Status history
No status changes recorded since RecallRadar first saw this recall on 2026-09-13 11:53 UTC. Current status: terminated.
Source
Official record: https://api.fda.gov/device/enforcement.json?search=recall_number:%22Z-1139-2013%22
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