Severity
Moderate
ModerateClass IITerminated
FDA Devices recall · Reported May 2, 2018
MicroVue CIC-C1q EIA, Model A001. An enzyme immunoassay for the detection of circulating immune complexes in human serum or plasma. The assay uses highly pure, functional human C1q coated in the solid phase to capture immune complexes (CIC). In the first stage, CIC in the diluted patient samples and HAGG in the controls and standards are dispensed into the C1q coated assay wells. After incubation, unbound material is removed in a washing step and a ready to use conjugate (goat anti-human Ig-HR
There is a potential for the slope of the standard curve to fail to meet the assay validation requirements for the assay.
Compiled from official public sources by the editorial team.
Verify with FDA Devices →
Diagnostic Hybrids, Inc. recalled MicroVue CIC-C1q EIA, Model A001. An enzyme immunoassay for the detection of circulating… - a moderate-severity action.
MicroVue CIC-C1q EIA, Model A001. An enzyme immunoassay for the detection of circulating… was recalled by Diagnostic Hybrids, Inc. in May 2, 2018. Reason: There is a potential for the slope of the standard curve to fail to meet the assay validation requirements fo…. Check the official notice for the remedy. Verify recall #Z-1496-2018 with the FDA Devices before acting.
The recall
Diagnostic Hybrids, Inc. issued this moderate-severity FDA Devices recall-There is a potential for the slope of the standard curve to fail to meet the assay validation requirements fo….
- Moderate
- severity level
- Class II
- classification
- May 2, 2018
- reported
Sourced from official FDA Devices enforcement records. Verify recall #Z-1496-2018 with the agency before acting. Full product description, hazard, remedy, and related recalls are below.
Recall Insight
This FDA Devices action (record #Z-1496-2018) was formally reported on May 2, 2018, with the manufacturer initiating the action on April 4, 2017. It is classified under Moderate severity (Class II), with a current status of Terminated. Diagnostic Hybrids, Inc. is listed as the recalling firm, operating out of Athens, OH. Federal records list the affected scope as 101 kits.
The documented reason for this recall is: There is a potential for the slope of the standard curve to fail to meet the assay validation requirements for the assay. Distribution data in the federal record shows the product reached: The products were distributed to the following US states: NY, TX, CO, UT. The products were distributed to the following foreign countries: Switzerland.. 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
101 kits
Related Recalls
6
3 from same agency
Product description
MicroVue CIC-C1q EIA, Model A001. An enzyme immunoassay for the detection of circulating immune complexes in human serum or plasma. The assay uses highly pure, functional human C1q coated in the solid phase to capture immune complexes (CIC). In the first stage, CIC in the diluted patient samples and HAGG in the controls and standards are dispensed into the C1q coated assay wells. After incubation, unbound material is removed in a washing step and a ready to use conjugate (goat anti-human Ig-HRP) is added. After a second incubation, unbound conjugate is washed away. After addition of a substrate and a short incubation interval, the quantity of CIC in the sample (¿g Eq/ml) can be determined by comparison to a standard curve.
Reason for recall
There is a potential for the slope of the standard curve to fail to meet the assay validation requirements for the assay.
Recall Profile
| Attribute | Value |
|---|---|
| Agency | U.S. Food and Drug Administration |
| Severity class | Moderate (Class II) |
| Status | Terminated |
| Recall number | Z-1496-2018 |
| Date reported | May 2, 2018 |
| Date initiated | April 4, 2017 |
| Recalling firm | Diagnostic Hybrids, Inc. |
| Firm location | Athens, OH |
| Affected scope | 101 kits |
| Distribution | The products were distributed to the following US states: NY, TX, CO, UT. The products were distributed to the following foreign countries: 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-1496-2018) 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.
Frequently Asked Questions
What product was recalled? ▼
MicroVue CIC-C1q EIA, Model A001. An enzyme immunoassay for the detection of circulating immune complexes in human serum or plasma. The assay uses highly pure, functional human C1q coated in the solid phase to capture immune complexes (CIC). In the first stage, CIC in the diluted patient samples and HAGG in the controls and standards are dispensed into the C1q coated assay wells. After incubation, unbound material is removed in a washing step and a ready to use conjugate (goat anti-human Ig-HRP) is added. After a second incubation, unbound conjugate is washed away. After addition of a substrate and a short incubation interval, the quantity of CIC in the sample (¿g Eq/ml) can be determined by comparison to a standard curve.. Recalled by Diagnostic Hybrids, Inc.. Units affected: 101 kits.
Why was this product recalled? ▼
There is a potential for the slope of the standard curve to fail to meet the assay validation requirements for the assay.
Which agency issued this recall? ▼
This recall was issued by the FDA Devices on May 2, 2018. Severity: Moderate. Recall number: Z-1496-2018.
Where was the recalled product distributed? ▼
Distribution: The products were distributed to the following US states: NY, TX, CO, UT. The products were distributed to the following foreign countries: Switzerland..
How do I check if my product is affected by a recall? ▼
Check the product description and recall number (Z-1496-2018) 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 May 2, 2018. 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.