Z-1139-2013Class II

Alere Cholestech LDX ALT AST Test Cassette, Model #12-788. For the in vitro quantitative determination of...

Name: Z-1139-2013 Alere Cholestech LDX ALT AST Test Cassette, Model #12-788. For the in vitro quantitative determination of...
Creator: Alere San Diego, Inc.
Published: 2013-03-06
License: https://open.fda.gov/license/

Alere San Diego, Inc. / initiated 2013-03-06 / Terminated

FDA source

Alere San Diego, Inc. began a recall of Alere Cholestech LDX ALT AST Test Cassette, Model #12-788. For the in vitro quantitative determination of alanine aminotransferase (ALT) and aspartate... on 2013-03-06. FDA classified it as Class II and gives the reason as "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...". As of 2026-09-10, the recall status on record is Terminated.

Recall record

Recall number: Z-1139-2013
Classification: Class II
Status: Terminated
Initiated: 2013-03-06
Posted: 2013-04-17
Terminated: 2013-08-13
Recalling firm: Alere San Diego, Inc.
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).
Product code: CKD Hydrazone Colorimetry, Alt/Sgpt
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.
FDA root cause: Other
Action: Alere sent an "URGENT MEDICAL DEVICE RECALL UPDATE" letter dated March 6, 2013 to all affected customers. The letter informed the customers of the problem identified and the actions to be taken. Customers with any questions about the recall notification, are instructed to contact Alere San Diego 9975 Summers Ridge Rd, San Diego, CA 92121; (877) 308-8289; Fax: (858) 805-8457. Customers are instructed to complete the customer response form even if they do not have any involved product.
Quantity in commerce: 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.
Product codes and lots: 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.

Enforcement reports

One row per recalled product line

FDA enforcement reports joined to recall event Z-1139-2013
Recall number	Class	Status	Voluntary or mandated	Report date	Classified
Z-1139-2013	Class II	Terminated	Voluntary: Firm initiated	2013-04-24	2013-04-17

Product code CKD

MDM coverage of this record lists here, newest first.

About this record

Sourced from the FDA device recall database and the FDA enforcement reports, both ingested from openFDA. The recall record supplies the product, the reason and the product code; the enforcement report supplies the classification. The two datasets are exported by FDA on different days, and the date above is the older of the two, so nothing on this page is newer than it says.

MDM adds the root cause tag, derived from FDA’s own root cause text, and the cross-links to the product code, the clearances named on the record and MDM coverage. Where a recall has not been joined to an enforcement report, no classification is shown.

Data as of 2026-09-30, the FDA export date for this dataset. Page last changed 2026-09-05. View this recall on fda.gov (opens on fda.gov)