FDA Devices recall · Reported July 25, 2012
Presage ST2 Assay, catalog numbers BC-1065 and BC-1065E. The Critical Diagnostics Presage ST2 Assay kit is an in vitro diagnostic device that quantitatively measures ST2 in serum or plasma by enzyme-linked immunosorbent assay (ELISA) in a microtiter plate format. The Presage ST2 Assay is indicated to be used in conjunction with clinical evaluation as an aid in assessing the prognosis of patients diagnosed with chronic heart failure.
The recall was initiated because Critical Diagnostics has confirmed that it is possible to obtain inaccurate test results for specimens when using the Presage ST2 Assay kits.
Critical Diagnostics recalled Presage ST2 Assay, catalog numbers BC-1065 and BC-1065E. The Critical Diagnostics Pres… - a low-severity action.
Presage ST2 Assay, catalog numbers BC-1065 and BC-1065E. The Critical Diagnostics Pres… was recalled by Critical Diagnostics in July 25, 2012. Reason: The recall was initiated because Critical Diagnostics has confirmed that it is possible to obtain inaccurate …. Check the official notice for the remedy. Verify recall #Z-2012-2012 with the FDA Devices before acting.
The recall
Critical Diagnostics issued this low-severity FDA Devices recall-The recall was initiated because Critical Diagnostics has confirmed that it is possible to obtain inaccurate ….
- Low
- severity level
- 33 units
- affected scope
- Class III
- classification
- July 25, 2012
- reported
Sourced from official FDA Devices enforcement records. Verify recall #Z-2012-2012 with the agency before acting. Full product description, hazard, remedy, and related recalls are below.
Recall Insight
This recall's affected scope, documented in the Recall Profile below, stays within a single-region or limited-distribution footprint. Distribution scope (see Distribution below) 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, 6 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 - 41,021 medical devices recalls on record
Of 88,244 recalls with an agency hazard classification, 19,068 are high severity, 64,652 moderate, and 4,524 low. A further 16,179 CPSC/NHTSA recalls have no agency class and are excluded from this split. 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.
Product description
Presage ST2 Assay, catalog numbers BC-1065 and BC-1065E. The Critical Diagnostics Presage ST2 Assay kit is an in vitro diagnostic device that quantitatively measures ST2 in serum or plasma by enzyme-linked immunosorbent assay (ELISA) in a microtiter plate format. The Presage ST2 Assay is indicated to be used in conjunction with clinical evaluation as an aid in assessing the prognosis of patients diagnosed with chronic heart failure.
Reason for recall
The recall was initiated because Critical Diagnostics has confirmed that it is possible to obtain inaccurate test results for specimens when using the Presage ST2 Assay kits.
Recall Profile
| Attribute | Value |
|---|---|
| Agency | U.S. Food and Drug Administration |
| Severity class | Low (Class III) |
| Status | Terminated |
| Recall number | Z-2012-2012 |
| Date reported | July 25, 2012 |
| Date initiated | February 28, 2012 |
| Recalling firm | Critical Diagnostics |
| Firm location | San Diego, CA |
| Affected scope | 33 units |
| Distribution | USA including the state of California and the countries of Austria, Spain, United Kingdom, and Italy. |
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-2012-2012) 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.
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Nationwide recalls with similar severity or category timing
Drug and device notices outside this firm and state, matched by severity timing and product category.
Similar severity · nearest report date
Same archive severity grade (Low), closest by report date among other firms and states.
Similar Medical Devices · nearest report date
Same product category, closest by report date among other firms and states (deduped against the severity set).
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Methodology · Corrections · Archive as of August 2026