ModerateClass IIOngoing

FDA Devices recall · Reported April 10, 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 intended for whole genome or de novo sequencing Product Name Installer /SKU /Updater SKU: (1) Torrent Suite Dx Software 5.14 -A52422/ A52417 (2) Torrent Suite Dx Software 5.12.5-

Q: Which agency issued this recall?

This recall was issued by the FDA Devices on April 10, 2024. Severity: Moderate. Recall number: Z-1426-2024.

Q: Where was the recalled product distributed?

Distribution: US Nationwide distribution in the states of CA, IN, NC OR, TN..

Q: How do I check if my product is affected by a recall?

Check the product description and recall number (Z-1426-2024) 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.

Q: 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.

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…

Recall #: Z-1426-2024
Affected scope: 28 units
Initiated: February 7, 2024

Compiled from official public sources by the editorial team. · Updated July 2026

Verify with FDA Devices →

View my saved recalls

Life Technologies Corporation recalled Torrent Suite Dx Software versions 5.14 and earlier used in connection with Ion PGM DX Sy… - a moderate-severity action.

Torrent Suite Dx Software versions 5.14 and earlier used in connection with Ion PGM DX Sy… was recalled by Life Technologies Corporation in April 10, 2024. Reason: Torrent Suite Dx Software versions 5.14 and earlier used in connection with Ion PGM DX Systems exploitation o…. Check the official notice for the remedy. Verify recall #Z-1426-2024 with the FDA Devices before acting.

Share: Post Facebook LinkedIn WhatsApp Email

The recall

Life Technologies Corporation issued this moderate-severity FDA Devices recall-Torrent Suite Dx Software versions 5.14 and earlier used in connection with Ion PGM DX Systems exploitation o….

Moderate
severity level: 28 units
affected scope: Class II
classification: April 10, 2024
reported

Sourced from official FDA Devices enforcement records. Verify recall #Z-1426-2024 with the agency before acting. Full product description, hazard, remedy, and related recalls are below.

Recall Insight

This FDA Devices action (record #Z-1426-2024) was formally reported on April 10, 2024, with the manufacturer initiating the action on February 7, 2024. It is classified under Moderate severity (Class II), with a current status of Ongoing. Life Technologies Corporation is listed as the recalling firm, operating out of Frederick, MD. Federal records list the affected scope as 28 units.

The documented reason for this recall is: 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 t… Distribution data in the federal record shows the product reached: US Nationwide distribution in the states of CA, IN, NC OR, TN.. 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.

Where this recall sits in the database

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.

Severity

Moderate

Affected scope

28 units

Related Recalls

3 from same agency

Product description

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 intended for whole genome or de novo sequencing Product Name Installer /SKU /Updater SKU: (1) Torrent Suite Dx Software 5.14 -A52422/ A52417 (2) Torrent Suite Dx Software 5.12.5- A46166/ A46167 (3)Torrent Suite Dx Software 5.8- A36601/ A36602 (4)Torrent Suite Dx Software 5.6.4- A33178/ A33178 (5)Torrent Suite Dx Software 5.0- A29166/ A29166

Reason for recall

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

Recall Profile

Structured summary of the FDA Devices recall record
Attribute	Value
Agency	U.S. Food and Drug Administration
Severity class	Moderate (Class II)
Status	Ongoing
Recall number	Z-1426-2024
Date reported	April 10, 2024
Date initiated	February 7, 2024
Recalling firm	Life Technologies Corporation
Firm location	Frederick, MD
Affected scope	28 units
Distribution	US Nationwide distribution in the states of CA, IN, NC OR, TN.

Profile values are sourced directly from the official FDA Devices enforcement record. Source: U.S. Food and Drug Administration.

Scale of Impact

28 units units affected - limited or regional distribution scale.

Regional (<10K units) ✓ This recall

Multi-state (10K – 100K units) -

Large-scale (100K – 1M units) -

Massive (≥1M units) -

Bracket cutoffs follow federal recall-disclosure conventions; bar widths scale linearly within each bracket. Source: PlainRecalls analysis of U.S. Food and Drug Administration filings.

What to do with this recall

Match your product against the recall record, then act on the agency remedy.

Check the recall number (Z-1426-2024) 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? ▼

Why was this product recalled? ▼

Which agency issued this recall? ▼

This recall was issued by the FDA Devices on April 10, 2024. Severity: Moderate. Recall number: Z-1426-2024.

Where was the recalled product distributed? ▼

Distribution: US Nationwide distribution in the states of CA, IN, NC OR, TN..

How do I check if my product is affected by a recall? ▼

Check the product description and recall number (Z-1426-2024) 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

Daikin Comfort Technologies Manufacturing Recalls Amana Air Conditioners and Heat Pumps Due to Risk of Serious Injury f…

· 2026-06-25

CPSC Moderate

Arizer Solo III Portable Vaporizers Recalled Due to Fire and Burn Hazards; Risk of Serious Injury or Death; Imported by…

· 2026-06-18

FDA Devices Moderate

GE HealthCare TRADE IN CARESCAPE TELEMETRY SERVER ARK-2250L - NORTH AMERICA, REF #5697603-902, Product Code KSA; used i…

GE Medical Systems Information Technologies Inc · 2026-06-03

FDA Devices Critical

Medline kits containing Huons Co. Bupivacaine HCL in Dextrose Injection, USP, labeled as: 1) BLOCK TRAY, Medline Kit…

Medline Industries, LP · 2026-06-03

Compare this recall with Rowenta Recalls Cordless Vacuum Cleaners Due to Risk of Ser… →

Browse all Medical Devices recalls →

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 April 10, 2024. 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.