Severity
Low
LowClass IIITerminated
FDA Devices recall · Reported August 29, 2018
is a quantitative/qualitative enzyme-linked immunosorbent assay (ELISA) for the detection of IgG and IgM autoantibodies specific for the phospholipid cardiolipin in human serum and EDTA, lithium heparin or citrated plasma. It is intended to assess anti-cardiolipin IgM autoantibody levels in patients where this information is useful in diagnosis, particularly in the assessment of thrombotic risk in patients with systemic lupus erythematosus, or other lupus-like disorders.
Incorrectly labeled Manufactured by DiaSorin, The correct term should be Distributed by DiaSorin.
Compiled from official public sources by the editorial team.
Verify with FDA Devices →
Euro Diagnostica Ab recalled is a quantitative/qualitative enzyme-linked immunosorbent assay (ELISA) for the detection… - a low-severity action.
is a quantitative/qualitative enzyme-linked immunosorbent assay (ELISA) for the detection… was recalled by Euro Diagnostica Ab in August 29, 2018. Reason: Incorrectly labeled Manufactured by DiaSorin, The correct term should be Distributed by DiaSorin.. Check the official notice for the remedy. Verify recall #Z-2921-2018 with the FDA Devices before acting.
The recall
Euro Diagnostica Ab issued this low-severity FDA Devices recall-Incorrectly labeled Manufactured by DiaSorin, The correct term should be Distributed by DiaSorin..
- Low
- severity level
- 6 units
- affected scope
- Class III
- classification
- August 29, 2018
- reported
Sourced from official FDA Devices enforcement records. Verify recall #Z-2921-2018 with the agency before acting. Full product description, hazard, remedy, and related recalls are below.
Recall Insight
This FDA Devices action (record #Z-2921-2018) was formally reported on August 29, 2018, with the manufacturer initiating the action on October 21, 2016. It is classified under Low severity (Class III), with a current status of Terminated. Euro Diagnostica Ab is listed as the recalling firm, operating out of Malmo. Federal records list the affected scope as 6.
The documented reason for this recall is: Incorrectly labeled Manufactured by DiaSorin, The correct term should be Distributed by DiaSorin. Distribution data in the federal record shows the product reached: MN. 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 - 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 - 40,422 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
6
Related Recalls
6
0 from same agency
Product description
is a quantitative/qualitative enzyme-linked immunosorbent assay (ELISA) for the detection of IgG and IgM autoantibodies specific for the phospholipid cardiolipin in human serum and EDTA, lithium heparin or citrated plasma. It is intended to assess anti-cardiolipin IgM autoantibody levels in patients where this information is useful in diagnosis, particularly in the assessment of thrombotic risk in patients with systemic lupus erythematosus, or other lupus-like disorders.
Reason for recall
Incorrectly labeled Manufactured by DiaSorin, The correct term should be Distributed by DiaSorin.
Recall Profile
| Attribute | Value |
|---|---|
| Agency | U.S. Food and Drug Administration |
| Severity class | Low (Class III) |
| Status | Terminated |
| Recall number | Z-2921-2018 |
| Date reported | August 29, 2018 |
| Date initiated | October 21, 2016 |
| Recalling firm | Euro Diagnostica Ab |
| Firm location | Malmo |
| Affected scope | 6 |
| Distribution | MN |
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-2921-2018) 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? ▼
is a quantitative/qualitative enzyme-linked immunosorbent assay (ELISA) for the detection of IgG and IgM autoantibodies specific for the phospholipid cardiolipin in human serum and EDTA, lithium heparin or citrated plasma. It is intended to assess anti-cardiolipin IgM autoantibody levels in patients where this information is useful in diagnosis, particularly in the assessment of thrombotic risk in patients with systemic lupus erythematosus, or other lupus-like disorders.. Recalled by Euro Diagnostica Ab. Units affected: 6.
Why was this product recalled? ▼
Incorrectly labeled Manufactured by DiaSorin, The correct term should be Distributed by DiaSorin.
Which agency issued this recall? ▼
This recall was issued by the FDA Devices on August 29, 2018. Severity: Low. Recall number: Z-2921-2018.
Where was the recalled product distributed? ▼
Distribution: MN.
How do I check if my product is affected by a recall? ▼
Check the product description and recall number (Z-2921-2018) 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.
Nearby Recalls in This Category
Other recalls in the same product category, useful for spotting patterns across the same defect class or manufacturer.
CPSC Moderate
Rowenta Recalls Cordless Vacuum Cleaners Due to Risk of Serious Injury from Fire and Burn Hazards
· 2026-07-02
CPSC Moderate
Winco Fireworks International Recalls Roman Candles 8 Shot Fireworks Due to Risk of Serious Injury from Explosion and B…
· 2026-07-02
CPSC Moderate
Winco Fireworks International Recalls Unity 7 Shot 200 Gram Aerial Cake Fireworks Due to Risk of Serious Injury from Ex…
· 2026-07-02
CPSC Moderate
Daikin Comfort Technologies Manufacturing Recalls Amana Air Conditioners and Heat Pumps Due to Risk of Serious Injury f…
· 2026-06-25
CPSC Moderate
Super Off-Road Solar Power Banks Recalled Due to Overheating; Imported by Spector & Co.
· 2026-06-25
Compare this recall with Rowenta Recalls Cordless Vacuum Cleaners Due to Risk of Ser… →
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 August 29, 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.