Severity
Moderate
ModerateClass IITerminated
FDA Devices recall · Reported March 14, 2018
DIASTAT anti-Nuclear antibody (ANA) / DIASTAT ANA ELISA. Catalog Number: FANA200. Product Usage: The DIASTAT¿ anti-nuclear antibody (ANA) test is a qualitative enzyme-linked immunosorbent assay (ELISA) for the detection of ANAs in human serum or EDTA plasma. It detects ANAs against Sm, Sm/RNP, Ro (SS-A), La (SS-B), Scl- 70, Jo-1, dsDNA, histone and centromere antigens.The test may be used to screen out samples which are negative for all ANAs. Samples that give a positive test result should b
Complaint investigation concluded that although product quality requirements stated in the instructions for use were met at lot release, the high background in the ELISA plate, t…
Euro Diagnostica Ab recalled DIASTAT anti-Nuclear antibody (ANA) / DIASTAT ANA ELISA. Catalog Number: FANA200. Prod… - a moderate-severity action.
DIASTAT anti-Nuclear antibody (ANA) / DIASTAT ANA ELISA. Catalog Number: FANA200. Prod… was recalled by Euro Diagnostica Ab in March 14, 2018. Reason: Complaint investigation concluded that although product quality requirements stated in the instructions for …. Check the official notice for the remedy. Verify recall #Z-0929-2018 with the FDA Devices before acting.
The recall
Euro Diagnostica Ab issued this moderate-severity FDA Devices recall-Complaint investigation concluded that although product quality requirements stated in the instructions for ….
- Moderate
- severity level
- 1K units
- affected scope
- Class II
- classification
- March 14, 2018
- reported
Sourced from official FDA Devices enforcement records. Verify recall #Z-0929-2018 with the agency before acting. Full product description, hazard, remedy, and related recalls are below.
Recall Insight
This FDA Devices action (record #Z-0929-2018) was formally reported on March 14, 2018, with the manufacturer initiating the action on October 15, 2015. It is classified under Moderate severity (Class II), with a current status of Terminated. Euro Diagnostica Ab is listed as the recalling firm, operating out of Malmo, N/A. Federal records list the affected scope as 1090.
The documented reason for this recall is: Complaint investigation concluded that although product quality requirements stated in the instructions for use were met at lot release, the high background in the ELISA plate, the strong IgM conjugate, and the low re… Distribution data in the federal record shows the product reached: Worldwide Distribution and US. Nationwide. 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, 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 - 40,861 medical devices recalls on record
Of 88,001 recalls with an agency hazard classification, 19,020 are high severity, 64,468 moderate, and 4,513 low. A further 16,157 CPSC/NHTSA recalls have no agency class and are excluded from this split. 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
1090
Related Recalls
6
6 from same agency
Product description
DIASTAT anti-Nuclear antibody (ANA) / DIASTAT ANA ELISA. Catalog Number: FANA200. Product Usage: The DIASTAT¿ anti-nuclear antibody (ANA) test is a qualitative enzyme-linked immunosorbent assay (ELISA) for the detection of ANAs in human serum or EDTA plasma. It detects ANAs against Sm, Sm/RNP, Ro (SS-A), La (SS-B), Scl- 70, Jo-1, dsDNA, histone and centromere antigens.The test may be used to screen out samples which are negative for all ANAs. Samples that give a positive test result should be further tested to identify the antigen-specific antibody or antibodies present. Quantitative/qualitative ELISA kits are available for the individual detection of Sm, Sm/RNP, Ro (SS-A), La (SS-B), dsDNA and centromere ANAs. Qualitative kits are available for the individual detection of Scl-70 and Jo-1. ANA detection represents one parameter in a multicriterion diagnostic process.
Reason for recall
Complaint investigation concluded that although product quality requirements stated in the instructions for use were met at lot release, the high background in the ELISA plate, the strong IgM conjugate, and the low reference control led to an increased risk of equivocal and/or false positive sample test results for the two FANA200 kit lots SS 1500 and SS 2009.
Recall Profile
| Attribute | Value |
|---|---|
| Agency | U.S. Food and Drug Administration |
| Severity class | Moderate (Class II) |
| Status | Terminated |
| Recall number | Z-0929-2018 |
| Date reported | March 14, 2018 |
| Date initiated | October 15, 2015 |
| Recalling firm | Euro Diagnostica Ab |
| Firm location | Malmo, N/A |
| Affected scope | 1090 |
| Distribution | Worldwide Distribution and US. Nationwide |
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-0929-2018) 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? ▼
DIASTAT anti-Nuclear antibody (ANA) / DIASTAT ANA ELISA. Catalog Number: FANA200. Product Usage: The DIASTAT¿ anti-nuclear antibody (ANA) test is a qualitative enzyme-linked immunosorbent assay (ELISA) for the detection of ANAs in human serum or EDTA plasma. It detects ANAs against Sm, Sm/RNP, Ro (SS-A), La (SS-B), Scl- 70, Jo-1, dsDNA, histone and centromere antigens.The test may be used to screen out samples which are negative for all ANAs. Samples that give a positive test result should be further tested to identify the antigen-specific antibody or antibodies present. Quantitative/qualitative ELISA kits are available for the individual detection of Sm, Sm/RNP, Ro (SS-A), La (SS-B), dsDNA and centromere ANAs. Qualitative kits are available for the individual detection of Scl-70 and Jo-1. ANA detection represents one parameter in a multicriterion diagnostic process.. Recalled by Euro Diagnostica Ab. Units affected: 1090.
Why was this product recalled? ▼
Complaint investigation concluded that although product quality requirements stated in the instructions for use were met at lot release, the high background in the ELISA plate, the strong IgM conjugate, and the low reference control led to an increased risk of equivocal and/or false positive sample test results for the two FANA200 kit lots SS 1500 and SS 2009.
Which agency issued this recall? ▼
This recall was issued by the FDA Devices on March 14, 2018. Severity: Moderate. Recall number: Z-0929-2018.
Where was the recalled product distributed? ▼
Distribution: Worldwide Distribution and US. Nationwide.
How do I check if my product is affected by a recall? ▼
Check the product description and recall number (Z-0929-2018) 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.
Nationwide recalls with similar severity or category timing
Two federal-filing-derived peer sets for this notice, both outside the same recalling firm and filing state so the neighborhoods are not firm or geographic containment.
Similar severity · nearest report date
Same archive severity grade (Moderate), 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).
Nearby Recalls in This Category
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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 March 14, 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 August 2026.