Device recall: Torrent Suite Dx Software versions 5.14 and earlier used in connection with Ion PGM DX Systems-IVD intended for…
Class II FDA enforcement event 94122. Recall start date: . Status in the FDA record: Ongoing.
Reason for recall, in the words of FDA
Torrent Suite Dx Software versions 5.14 and earlier used in connection with Ion PGM DX Systems exploitation of the vulnerability by a threat actor may allow them to alter settings, configurations, software, or data on the instrument
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
Life Technologies Corporation started this device recall on 7 Feb 2024. The firm address in the FDA record is in Frederick, MD. FDA put the recall in Class II. FDA event 94122 has 1 product record. The first FDA enforcement report date is 10 Apr 2024. 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 Nationwide distribution in the states of CA, IN, NC OR, TN.
Recalling firm
Life Technologies Corporation, Frederick, MD.
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-1426-2024 | Torrent Suite Dx Software versions 5.14 and earlier used in connection with Ion PGM DX Systems-IVD intended for targeted sequencing of human genomic DNA (gDNA) from peripheral whole-blood samples and DNA and RNA extracted from formalin-fixed, paraffin-embedded (FFPE) samples. The Ion PGM Dx Instrument System is not… | 28 units | Class II | Ongoing | 10 Apr 2024 |
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 2024
- 970
- Share of these events in Class II
- 87%
- Product records in this event
- 1Median of the firm: 1
- Events of the firm on the register
- 8
Other events of the firm
| Initiated | Product (first record) | Type | Class | Records |
|---|---|---|---|---|
| 6 Aug 2020 | The TaqPath RT-PCR COVID-19 Kit with Applied Biosystem's COVID-19 Interpretive Software v1.2 for 7500 RTPCR instruments, | Device | Class II | 2 |
| 16 Mar 2020 | Oncomine Dx Target Test DNA Control-IVD for detection of DNA and RNA isolated from non-small cell lung cancer (NSCLC) tu | Device | Class II | 4 |
| 11 Jun 2019 | StemPro MSC SFM CTS" | Device | Class II | 2 |
| 8 Feb 2018 | Oncomine Dx Target Test, (Model No. A32451), Oncomine Dx Target RNA/DNA Panel (Model No. A32441). A qualitative In Vitro | Device | Class II | 1 |
| 7 Feb 2018 | Human Fetal Hemoglobin (HBF-1) FITC Conjugate | Device | Class II | 1 |
| 4 Dec 2017 | Oncomine Dx Target Test User Guides and Assay Definition File, Model: A32461; UDI: (01)10190302006071(11)170911(10)1.8(2 | Device | Class II | 1 |
| 13 May 2013 | HSV 2 Primers, Catalog #18081020. Analyte Specific Reagent. The HSV-2 primer pair is specific for HSV-2 (Herpes Simplex | Device | Class II | 1 |
Official channels
- FDA enforcement report Z-1426-2024The 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.
Follow by RSS:Food, drug and device recallsFDA Class I recalls
Cite this page
Recall Register. FDA enforcement event 94122. https://recallregister.com/fda/ii/94122/. 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 Nationwide distribution in the states of CA, IN, NC OR, TN.
- What quantity of product is in FDA event 94122?
- The FDA record gives this quantity:
28 units
- How did the recall start?
- The FDA record says:
Voluntary: Firm initiated
- How many device recalls of 2024 have the same class?
- 87% of the 970 device events that started in 2024 are in Class II.