FDA Devices recall · Reported May 2, 2018
Quidel MicroVue Intact PTH EIA, Model 8044. An enzyme immunoassay for the quantification of Intact Parathyroid Hormone (PTH) in serum.
There may be a loss of separation between Calibrators A and B which may impact the assay calibration at the lower end of the assay.
Diagnostic Hybrids, Inc. recalled Quidel MicroVue Intact PTH EIA, Model 8044. An enzyme immunoassay for the quantification… - a low-severity action.
Quidel MicroVue Intact PTH EIA, Model 8044. An enzyme immunoassay for the quantification… was recalled by Diagnostic Hybrids, Inc. in May 2, 2018. Reason: There may be a loss of separation between Calibrators A and B which may impact the assay calibration at the l…. Check the official notice for the remedy. Verify recall #Z-1520-2018 with the FDA Devices before acting.
The recall
Diagnostic Hybrids, Inc. issued this low-severity FDA Devices recall-There may be a loss of separation between Calibrators A and B which may impact the assay calibration at the l….
- Low
- severity level
- 26 units
- affected scope
- Class III
- classification
- May 2, 2018
- reported
Sourced from official FDA Devices enforcement records. Verify recall #Z-1520-2018 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
Quidel MicroVue Intact PTH EIA, Model 8044. An enzyme immunoassay for the quantification of Intact Parathyroid Hormone (PTH) in serum.
Reason for recall
There may be a loss of separation between Calibrators A and B which may impact the assay calibration at the lower end of the assay.
Recall Profile
| Attribute | Value |
|---|---|
| Agency | U.S. Food and Drug Administration |
| Severity class | Low (Class III) |
| Status | Terminated |
| Recall number | Z-1520-2018 |
| Date reported | May 2, 2018 |
| Date initiated | October 26, 2016 |
| Recalling firm | Diagnostic Hybrids, Inc. |
| Firm location | Athens, OH |
| Affected scope | 26 |
| Distribution | The product was distributed to the following countries: Singapore, Switzerland |
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-1520-2018) 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