Severity
Moderate
ModerateClass IITerminated
FDA Devices recall · Reported July 22, 2020
MOL2150 Simplexa HSV 1&2 Direct -CSF -Genital Swab -Cutaneous / Mucocutaneous Swabs Product Usage: is intended for use on the LIAISON MDX instrument for the qualitative detection and differentiation of HSV-1 and HSV-2 present in cerebrospinal fluid (CSF), or cutaneous and mucocutaneous lesion swabs from patients with signs and symptoms of HSV-1 or HSV-2 infection of the central nervous system (CNS) or cutaneous and mucocutaneous lesions.
Due to a software malfunction in the Multi Assay Suite, there is the probability of increased occurrence of false negative results.
Compiled from official public sources by the editorial team.
Verify with FDA Devices →
DiaSorin Molecular LLC recalled MOL2150 Simplexa HSV 1&2 Direct -CSF -Genital Swab -Cutaneous / Mucocutaneous Swabs Produ… - a moderate-severity action.
MOL2150 Simplexa HSV 1&2 Direct -CSF -Genital Swab -Cutaneous / Mucocutaneous Swabs Produ… was recalled by DiaSorin Molecular LLC in July 22, 2020. Reason: Due to a software malfunction in the Multi Assay Suite, there is the probability of increased occurrence of f…. Check the official notice for the remedy. Verify recall #Z-2547-2020 with the FDA Devices before acting.
The recall
DiaSorin Molecular LLC issued this moderate-severity FDA Devices recall-Due to a software malfunction in the Multi Assay Suite, there is the probability of increased occurrence of f….
- Moderate
- severity level
- Class II
- classification
- July 22, 2020
- reported
Sourced from official FDA Devices enforcement records. Verify recall #Z-2547-2020 with the agency before acting. Full product description, hazard, remedy, and related recalls are below.
Recall Insight
This FDA Devices action (record #Z-2547-2020) was formally reported on July 22, 2020, with the manufacturer initiating the action on May 12, 2020. It is classified under Moderate severity (Class II), with a current status of Terminated. DiaSorin Molecular LLC is listed as the recalling firm, operating out of Cypress, CA. Federal records list the affected scope as 13943 plastic vials (24 vials per box).
The documented reason for this recall is: Due to a software malfunction in the Multi Assay Suite, there is the probability of increased occurrence of false negative results. Distribution data in the federal record shows the product reached: Worldwide distribution - U.S. Nationwide distribution including in the states of CO, FL, KS, MI, NC, PA, TX, and WA The countries of Austria, Czech Republic, France and Switerland.. 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
13943 plastic vials (24 vials per box)
Related Recalls
6
3 from same agency
Product description
MOL2150 Simplexa HSV 1&2 Direct -CSF -Genital Swab -Cutaneous / Mucocutaneous Swabs Product Usage: is intended for use on the LIAISON MDX instrument for the qualitative detection and differentiation of HSV-1 and HSV-2 present in cerebrospinal fluid (CSF), or cutaneous and mucocutaneous lesion swabs from patients with signs and symptoms of HSV-1 or HSV-2 infection of the central nervous system (CNS) or cutaneous and mucocutaneous lesions.
Reason for recall
Due to a software malfunction in the Multi Assay Suite, there is the probability of increased occurrence of false negative results.
Recall Profile
| Attribute | Value |
|---|---|
| Agency | U.S. Food and Drug Administration |
| Severity class | Moderate (Class II) |
| Status | Terminated |
| Recall number | Z-2547-2020 |
| Date reported | July 22, 2020 |
| Date initiated | May 12, 2020 |
| Recalling firm | DiaSorin Molecular LLC |
| Firm location | Cypress, CA |
| Affected scope | 13943 plastic vials (24 vials per box) |
| Distribution | Worldwide distribution - U.S. Nationwide distribution including in the states of CO, FL, KS, MI, NC, PA, TX, and WA The countries of Austria, Czech Republic, France and Switerland. |
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-2547-2020) 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? ▼
MOL2150 Simplexa HSV 1&2 Direct -CSF -Genital Swab -Cutaneous / Mucocutaneous Swabs Product Usage: is intended for use on the LIAISON MDX instrument for the qualitative detection and differentiation of HSV-1 and HSV-2 present in cerebrospinal fluid (CSF), or cutaneous and mucocutaneous lesion swabs from patients with signs and symptoms of HSV-1 or HSV-2 infection of the central nervous system (CNS) or cutaneous and mucocutaneous lesions.. Recalled by DiaSorin Molecular LLC. Units affected: 13943 plastic vials (24 vials per box).
Why was this product recalled? ▼
Due to a software malfunction in the Multi Assay Suite, there is the probability of increased occurrence of false negative results.
Which agency issued this recall? ▼
This recall was issued by the FDA Devices on July 22, 2020. Severity: Moderate. Recall number: Z-2547-2020.
Where was the recalled product distributed? ▼
Distribution: Worldwide distribution - U.S. Nationwide distribution including in the states of CO, FL, KS, MI, NC, PA, TX, and WA The countries of Austria, Czech Republic, France and Switerland..
How do I check if my product is affected by a recall? ▼
Check the product description and recall number (Z-2547-2020) 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
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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 July 22, 2020. 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.