Device recall: Simplexa Direct Amplification Disc Kit, Product Kit Code MOL1455
Class II FDA enforcement event 89098. Recall start date: . Status in the FDA record: Ongoing.
Reason for recall, in the words of FDA
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.
Class II, in the words of FDA
a situation in which use of or exposure to a violative product may cause temporary or medically reversible adverse health consequences or where the probability of serious adverse health consequences is remote
DiaSorin Molecular LLC started this device recall on 19 Nov 2021. The firm address in the FDA record is in Cypress, CA. FDA put the recall in Class II. FDA event 89098 has 1 product record. The first FDA enforcement report date is 12 Jan 2022. The record gives the status Ongoing.
It is important to note that most of the time recall classifications are determined after the recalling firm provides all of the information needed to determine the risk posed to public health. The classification and posting in the FDA Enforcement Report should not be seen as an expansion or change to a firm’s voluntary public warning.
FDA publishes these words. Source: FDA, Enforcement Reports, Important Note, read on . openFDA export of .
Distribution
In the words of FDA.
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,…
Recalling firm
DiaSorin Molecular LLC, Cypress, CA.
Recalling firm: The firm that the FDA record names for a recall.
FDA records how the recall started: Voluntary: Firm initiated.
Products
1 product record in the event.
| Recall number | Product | Quantity | Class | Status | Report date |
|---|---|---|---|---|---|
| Z-0457-2022 | Simplexa Direct Amplification Disc Kit, Product Kit Code MOL1455 | 29495 kits | Class II | Ongoing | 12 Jan 2022 |
openFDA, about the status: FDA does not update the status of a recall after the recall has been classified according to its level of hazard. As such, the status of a recall (open, completed, or terminated) will remain unchanged after published in the Enforcement Reports.
Source: openFDA, Drug Recall Enforcement Reports, Disclaimer.
Enforcement report: The FDA publication that lists recalls. It has one record for each product of a recall.
Enforcement event: All the product records that have one FDA event number. This site shows one event on one page.
Class II: The middle of the three FDA recall classes.
The event in context
- Device events that started in 2021
- 900
- Share of these events in Class II
- 89%
- Product records in this event
- 1Median of the firm: 1
- Events of the firm on the register
- 5
Other events of the firm
| Initiated | Product (first record) | Type | Class | Records |
|---|---|---|---|---|
| 14 Jun 2023 | Simplexa Direct Amplification Disc Kit, Rx Only, IVD The Simplexa Direct Amplification Disc Kit, REF: MOL1455 is 1 box c | Device | Class II | 1 |
| 30 Jan 2023 | Simplexa COVID-19 Direct, REF: MOL4150; including Reaction Mix, REF: MOL4150; with previous assay definition v2 | Device | Class II | 2 |
| 23 Sep 2021 | SIMPLEXA COVID-19 Positive Control Pack, REF MOL4160, IVD, Rx Only, UDI: (01) 20816101027051 | Device | Class II | 1 |
| 12 May 2020 | MOL2150 Simplexa HSV 1&2 Direct -CSF -Genital Swab -Cutaneous / Mucocutaneous Swabs Product Usage: is intended for use o | Device | Class II | 3 |
Official channels
- FDA enforcement report Z-0457-2022The FDA record of the first product of this event.
- FDA: recalls, market withdrawals and safety alertsThe recall notices on the FDA site.
- FDA MedWatchThe FDA safety reporting program for drugs and medical devices.
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Cite this page
Recall Register. FDA enforcement event 89098. https://recallregister.com/fda/ii/89098/. Source: openFDA enforcement reports. Data through .
Sources
- Source
- openFDA device enforcement reports
- Licence
- CC0 1.0
- Export date
- 28 Sep 2026
- Newest FDA report date on the register
- 23 Sep 2026
FDA has one record for each product. This site puts the records with the same event number on one page. The class of the event is the highest class of its records. How the register is made. Report an error.
Questions
- Where was the product distributed?
- The FDA record gives this 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,…
- What quantity of product is in FDA event 89098?
- The FDA record gives this quantity:
29495 kits
- How did the recall start?
- The FDA record says:
Voluntary: Firm initiated
- How many device recalls of 2021 have the same class?
- 89% of the 900 device events that started in 2021 are in Class II.