Severity
Moderate
ModerateClass IITerminated
FDA Devices recall · Reported April 24, 2013
Alere Cholestech LDX ALT AST Test Cassette, Model #12-788. For the in vitro quantitative determination of alanine aminotransferase (ALT) and aspartate aminotransferase (AST).
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…
Compiled from official public sources by the editorial team.
Verify with FDA Devices →
Alere San Diego, Inc. recalled Alere Cholestech LDX ALT AST Test Cassette, Model #12-788. For the in vitro quantitati… - a moderate-severity action.
Alere Cholestech LDX ALT AST Test Cassette, Model #12-788. For the in vitro quantitati… was recalled by Alere San Diego, Inc. in April 24, 2013. Reason: The recall was initiated because Alere San Diego has an update for the Alere Cholestech LDX ALT AST cassette,…. Check the official notice for the remedy. Verify recall #Z-1139-2013 with the FDA Devices before acting.
The recall
Alere San Diego, Inc. issued this moderate-severity FDA Devices recall-The recall was initiated because Alere San Diego has an update for the Alere Cholestech LDX ALT AST cassette,….
- Moderate
- severity level
- Class II
- classification
- April 24, 2013
- reported
Sourced from official FDA Devices enforcement records. Verify recall #Z-1139-2013 with the agency before acting. Full product description, hazard, remedy, and related recalls are below.
Recall Insight
This FDA Devices action (record #Z-1139-2013) was formally reported on April 24, 2013, with the manufacturer initiating the action on March 6, 2013. It is classified under Moderate severity (Class II), with a current status of Terminated. Alere San Diego, Inc. is listed as the recalling firm, operating out of San Diego, CA. Federal records list the affected scope as 38,571 kits.
The documented reason for this recall is: 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 … Distribution data in the federal record shows the product reached: 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.. Distribution scope directly affects the consumer exposure window and determines whether a recall remains regional or escalates into a nationwide advisory.
Within the same product category the archive holds 6 closely related recalls, 3 from FDA Devices - clustering in a narrow category often points to a systemic quality-control or supplier issue rather than a one-off defect. Always verify the recall number against the official agency record before acting.
Medical Devices recalls over time
Where this recall sits in its category - 40,322 medical devices recalls on record
Of 101,704 recalls in the database, 24,878 are high severity, 72,426 moderate, and 4,400 low. This recall is classified moderate severity.
Counts reflect market size and reporting activity, not inherent danger, we do not rank products by risk from raw recall volume.
Affected scope
38,571 kits
Related Recalls
6
3 from same agency
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.
Recall Profile
| Attribute | Value |
|---|---|
| Agency | U.S. Food and Drug Administration |
| Severity class | Moderate (Class II) |
| Status | Terminated |
| Recall number | Z-1139-2013 |
| Date reported | April 24, 2013 |
| Date initiated | March 6, 2013 |
| Recalling firm | Alere San Diego, Inc. |
| Firm location | San Diego, CA |
| Affected scope | 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. |
Profile values are sourced directly from the official FDA Devices enforcement record. Source: U.S. Food and Drug Administration.
What to do with this recall
Match your product against the recall record, then act on the agency remedy.
- Check the recall number (Z-1139-2013) and product description against the item you own. Search the archive
- Confirm the current status with FDA Devices before acting, recall details can be updated.
- Follow the documented remedy (refund, replacement, repair, or disposal) rather than general advice. What to do next
This page summarizes the official FDA Devices record for research and awareness; it is not legal, medical, or safety advice. Verify with the issuing agency before acting.
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.
Where was the recalled product distributed? ▼
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..
How do I check if my product is affected by a recall? ▼
Check the product description and recall number (Z-1139-2013) against your product. Visit the official FDA Devices website for the most current information. You can also use our Recall Checker tool to search by product name or brand.
Should I stop using a recalled medication or medical device? ▼
Do not stop using a recalled medication or device without consulting your healthcare provider first, as abruptly discontinuing treatment could pose its own health risks. Your doctor can advise on alternatives or whether the recall applies to your specific product lot. Check the recall number and lot information against your product packaging.
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Every figure on PlainRecalls is rendered directly from official FDA, CPSC and NHTSA recall records, no number is typed in by an editor. This recall: FDA Devices, reported April 24, 2013. Severity classes follow each agency's own taxonomy (FDA Class I/II/III; CPSC and NHTSA by hazard type), and related-recall context is computed across the full archive. See our editorial standards & corrections policy, the methodology behind these numbers, or report a data error. Data current as of July 2026.