Severity
Moderate
ModerateClass IIOngoing
FDA Devices recall · Reported January 12, 2022
Simplexa Direct Amplification Disc Kit, Product Kit Code MOL1455
A subset of affected discs are at risk of leakage when it is used more than one time with Simplexa COVID-19 Direct and/or Simplexa Flu A/B & RSV Direct Gen II. Leakage from a well…
DiaSorin Molecular LLC recalled Simplexa Direct Amplification Disc Kit, Product Kit Code MOL1455 - a moderate-severity action.
Simplexa Direct Amplification Disc Kit, Product Kit Code MOL1455 was recalled by DiaSorin Molecular LLC in January 12, 2022. Reason: A subset of affected discs are at risk of leakage when it is used more than one time with Simplexa COVID-19 D…. Check the official notice for the remedy. Verify recall #Z-0457-2022 with the FDA Devices before acting.
The recall
DiaSorin Molecular LLC issued this moderate-severity FDA Devices recall-A subset of affected discs are at risk of leakage when it is used more than one time with Simplexa COVID-19 D….
- Moderate
- severity level
- Class II
- classification
- January 12, 2022
- reported
Sourced from official FDA Devices enforcement records. Verify recall #Z-0457-2022 with the agency before acting. Full product description, hazard, remedy, and related recalls are below.
Recall Insight
This FDA Devices action (record #Z-0457-2022) was formally reported on January 12, 2022, with the manufacturer initiating the action on November 19, 2021. It is classified under Moderate severity (Class II), with a current status of Ongoing. DiaSorin Molecular LLC is listed as the recalling firm, operating out of Cypress, CA. Federal records list the affected scope as 29495 kits.
The documented reason for this recall is: A subset of affected discs are at risk of leakage when it is used more than one time with Simplexa COVID-19 Direct and/or Simplexa Flu A/B & RSV Direct Gen II. Leakage from a well that had a positive sample may cause fu… Distribution data in the federal record shows the product reached: US: AZ, CA, CO, CT, DC, FL, GA, HI, IA, IL, IN, KS, KY, LA, MA, MD, ME, MI, MN, MO, NC, ND, NE, NH, NJ, NM, NV, NY, OH, PA, RI, SC, SD, TN, TX, VA, VT, WA, WI, WV; and Worldw…. 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
29495 kits
Related Recalls
6
6 from same agency
Product description
Simplexa Direct Amplification Disc Kit, Product Kit Code MOL1455
Reason for recall
A subset of affected discs are at risk of leakage when it is used more than one time with Simplexa COVID-19 Direct and/or Simplexa Flu A/B & RSV Direct Gen II. Leakage from a well that had a positive sample may cause further cross-contamination in areas of the lab if not properly cleaned.
Recall Profile
| Attribute | Value |
|---|---|
| Agency | U.S. Food and Drug Administration |
| Severity class | Moderate (Class II) |
| Status | Ongoing |
| Recall number | Z-0457-2022 |
| Date reported | January 12, 2022 |
| Date initiated | November 19, 2021 |
| Recalling firm | DiaSorin Molecular LLC |
| Firm location | Cypress, CA |
| Affected scope | 29495 kits |
| Distribution | US: AZ, CA, CO, CT, DC, FL, GA, HI, IA, IL, IN, KS, KY, LA, MA, MD, ME, MI, MN, MO, NC, ND, NE, NH, NJ, NM, NV, NY, OH, PA, RI, SC, SD, TN, TX, VA, VT, WA, WI, WV; and Worldwide: Kuwait, Austr… |
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-0457-2022) 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? ▼
Simplexa Direct Amplification Disc Kit, Product Kit Code MOL1455. Recalled by DiaSorin Molecular LLC. Units affected: 29495 kits.
Why was this product recalled? ▼
A subset of affected discs are at risk of leakage when it is used more than one time with Simplexa COVID-19 Direct and/or Simplexa Flu A/B & RSV Direct Gen II. Leakage from a well that had a positive sample may cause further cross-contamination in areas of the lab if not properly cleaned.
Which agency issued this recall? ▼
This recall was issued by the FDA Devices on January 12, 2022. Severity: Moderate. Recall number: Z-0457-2022.
Where was the recalled product distributed? ▼
Distribution: US: AZ, CA, CO, CT, DC, FL, GA, HI, IA, IL, IN, KS, KY, LA, MA, MD, ME, MI, MN, MO, NC, ND, NE, NH, NJ, NM, NV, NY, OH, PA, RI, SC, SD, TN, TX, VA, VT, WA, WI, WV; and Worldwide: Kuwait, Australia, Israel, Italy, Canada, Chile, Puerto Rico, United Arab Emirates..
How do I check if my product is affected by a recall? ▼
Check the product description and recall number (Z-0457-2022) 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.
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Compare this recall with FARADRIVE STEERABLE SHEATH CLEAR, used to facilitate access… →
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 January 12, 2022. 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.