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Recall data is sourced from official U.S. government agencies (CPSC, FDA, NHTSA, USDA) and processed using AI to improve readability. This site is not affiliated with or endorsed by any government agency. Always refer to the original agency notice for authoritative information.

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Medium RiskFDA Device

Life Technologies Holdings Pte Ltd: Torrent SuiteTM Dx analysis software, a component of the Ion PGM Dx Instrument System, incorrectly displays a positive result when a different analytical or de novo variant is detected at the same locus as a specified clinical variant

Agency Publication Date: October 23, 2019
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Affected Products

Product: Torrent Suite Dx Software Version (IUO) 5.2 Catalog Number: A29225 OEM Customer Software: Sentosa SQ Suite Software v5.6.9

The field action is associated with the software available on the PGM Dx instrument, therefore no lot code is applicable for this part type

Lot Numbers:
code
Product: Torrent Suite Dx Software Version (IUO) 5.4 Catalog Number: A31774 OEM Customer Software: Sentosa SQ Suite Software v5.6.15

The field action is associated with the software available on the PGM Dx instrument, therefore no lot code is applicable for this part type

Lot Numbers:
code
Product: Torrent Suite Dx Software Version 5.6.4 Catalog Number:A33178 OEM Customer software: Sentosa SQ Suite Software v5.6.20 UDI: (01)10190302005654 (11)000000 (10)5.6.4 (240)A33178

The field action is associated with the software available on the PGM Dx instrument, therefore no lot code is applicable for this part type

Lot Numbers:
code
Product: Torrent Suite Dx Software Version 5.8 Catalog Number:A36601 and A36602 OEM Customer software: Torrent Suite Dx T430 Software v5.0 DARUI DR-SEQ 800 Software UDI:(01)10190302014090 (11)000000(10)5.8 (240)A36601

The field action is associated with the software available on the PGM Dx instrument, therefore no lot code is applicable for this part type

Lot Numbers:
code

Additional Information

Agency: Food and Drug Administration (FDA)
Event ID: 83786
Status: Resolved
Manufacturer: Life Technologies Holdings Pte Ltd
Manufactured In: Singapore
Units Affected: 4 products (total of Ion+vela +chassis =400 units)

Were You Affected by This Recall?

If you or a family member were harmed by this recalled product, you may have legal rights. Consider consulting a consumer protection attorney to understand your options for compensation.

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AI-Enhanced Content: The summary, action steps, and risk assessment on this page were generated by AI from official government recall data to improve readability. This is not legal or medical advice. Always refer to the official agency sources below for authoritative information.

Sources: FDA iRES · Raw API Response

openFDA Disclaimer: This recall information is sourced from the openFDA API. Do not rely on openFDA to make decisions regarding medical care. While we make every effort to ensure that data is accurate, you should assume all results are unvalidated. Refer to the openFDA terms of service for more information.