Severity
Low
LowClass IIITerminated
FDA Devices recall · Reported February 6, 2013
Alere Cholestech LDX Calibration Verification, 4 vial set, Catalog Number: 88770 Alere Cholestech LDX Calibration Verification (hereafter referred to as CAL VERS) enables users to monitor the performance of total cholesterol (TC), high density lipoprotein cholesterol (HDL), triglycerides (TRG), and glucose (GLU) test procedures on the Alere Cholestech LDX System. Calibration verification is optional for CLIA waived systems, such as the Alere Cholestech LDX System, under CLIA regulations. Howe
Out of range (increased) HDL Cholesterol results.
Compiled from official public sources by the editorial team.
Verify with FDA Devices →
Alere San Diego, Inc. recalled Alere Cholestech LDX Calibration Verification, 4 vial set, Catalog Number: 88770 Alere… - a low-severity action.
Alere Cholestech LDX Calibration Verification, 4 vial set, Catalog Number: 88770 Alere… was recalled by Alere San Diego, Inc. in February 6, 2013. Reason: Out of range (increased) HDL Cholesterol results.. Check the official notice for the remedy. Verify recall #Z-0747-2013 with the FDA Devices before acting.
The recall
Alere San Diego, Inc. issued this low-severity FDA Devices recall-Out of range (increased) HDL Cholesterol results..
- Low
- severity level
- Class III
- classification
- February 6, 2013
- reported
Sourced from official FDA Devices enforcement records. Verify recall #Z-0747-2013 with the agency before acting. Full product description, hazard, remedy, and related recalls are below.
Recall Insight
This FDA Devices action (record #Z-0747-2013) was formally reported on February 6, 2013, with the manufacturer initiating the action on October 22, 2012. It is classified under Low severity (Class III), 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 614 kits.
The documented reason for this recall is: Out of range (increased) HDL Cholesterol results. Distribution data in the federal record shows the product reached: Worldwide Distribution - USA (nationwide) Puerto Rico and South Korea.. 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 low severity.
Counts reflect market size and reporting activity, not inherent danger, we do not rank products by risk from raw recall volume.
Affected scope
614 kits
Related Recalls
6
3 from same agency
Product description
Alere Cholestech LDX Calibration Verification, 4 vial set, Catalog Number: 88770 Alere Cholestech LDX Calibration Verification (hereafter referred to as CAL VERS) enables users to monitor the performance of total cholesterol (TC), high density lipoprotein cholesterol (HDL), triglycerides (TRG), and glucose (GLU) test procedures on the Alere Cholestech LDX System. Calibration verification is optional for CLIA waived systems, such as the Alere Cholestech LDX System, under CLIA regulations. However local or state regulations may require that calibration verification is run at regular intervals.
Reason for recall
Out of range (increased) HDL Cholesterol results.
Recall Profile
| Attribute | Value |
|---|---|
| Agency | U.S. Food and Drug Administration |
| Severity class | Low (Class III) |
| Status | Terminated |
| Recall number | Z-0747-2013 |
| Date reported | February 6, 2013 |
| Date initiated | October 22, 2012 |
| Recalling firm | Alere San Diego, Inc. |
| Firm location | San Diego, CA |
| Affected scope | 614 kits |
| Distribution | Worldwide Distribution - USA (nationwide) Puerto Rico and South Korea. |
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-0747-2013) 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 Calibration Verification, 4 vial set, Catalog Number: 88770 Alere Cholestech LDX Calibration Verification (hereafter referred to as CAL VERS) enables users to monitor the performance of total cholesterol (TC), high density lipoprotein cholesterol (HDL), triglycerides (TRG), and glucose (GLU) test procedures on the Alere Cholestech LDX System. Calibration verification is optional for CLIA waived systems, such as the Alere Cholestech LDX System, under CLIA regulations. However local or state regulations may require that calibration verification is run at regular intervals.. Recalled by Alere San Diego, Inc.. Units affected: 614 kits.
Why was this product recalled? ▼
Out of range (increased) HDL Cholesterol results.
Which agency issued this recall? ▼
This recall was issued by the FDA Devices on February 6, 2013. Severity: Low. Recall number: Z-0747-2013.
Where was the recalled product distributed? ▼
Distribution: Worldwide Distribution - USA (nationwide) Puerto Rico and South Korea..
How do I check if my product is affected by a recall? ▼
Check the product description and recall number (Z-0747-2013) 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 February 6, 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.