Torrent Suite Dx Software Recalled for Incorrect Positive Variant Results
Life Technologies is recalling Torrent Suite Dx software because it may incorrectly display positive results for clinical variants.
The agency’s classification
FDA (Devices): Class II
Class II is 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.
This is the agency’s own classification, taken from its notice. The severity score below is our assessment, not the agency’s. How recall classes work
What this means for you
Our assessment, not the agency’s: severity 3/5 (High).
Real risk of harm even if no illness or injury has been reported yet. Stop using the product and follow the agency's guidance.
Our severity reasoning: The recall involves a medical device software defect that can lead to incorrect diagnostic results (false positives), which is a risk-of-harm product where injury has not yet been reported, fitting the 'High' severity criteria.
Plain-English summary
Life Technologies Holdings Pte Ltd is recalling Torrent Suite Dx analysis software, version 5.8, which is a component of the Ion PGM Dx Instrument System. The recall involves catalog numbers A36601 and A36602, as well as OEM customer software including Torrent Suite Dx T430 Software v5.0 and DARUI DR-SEQ 800 Software.
The software is being recalled because it incorrectly displays a positive result when a different analytical or de novo variant is detected at the same locus as a specified clinical variant. This error could lead to inaccurate diagnostic reporting.
The field action is associated with the software available on the PGM Dx instrument. The distribution includes 400 units of Ion+vela +chassis across various US states and international locations including South Korea, Italy, China, Japan, Singapore, Germany, Taiwan, and Poland. Users should contact the manufacturer for further instructions.
The recalled product
- 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
- Manufacturer
- Life Technologies Holdings Pte Ltd
- Category
- Medical Device — Software
- Affected units
- 400
Is your product affected?
Check your packaging against the codes below. If any of them match, the product is part of this recall.
Lot numbers (1)
- therefore no lot code is applicable for this part type
Distribution
Part of a larger recall action
This product is one of 4 recalled by Life Technologies Holdings Pte Ltd under a single FDA (Devices) recall action. The agency files each product separately, so the size of the action is not visible from this page alone.
See all 4 products in this recall →Related recalls
Same manufacturer · Life Technologies Holdings Pte Ltd
See all →- SevereTorrent Suite Dx Software Recalled for Incorrect Positive Variant Results
FDA (Devices) · 2019-10-30
- SevereLife Technologies Recalls Torrent Suite Dx Software for Incorrect Results
FDA (Devices) · 2019-10-30
- HighLife Technologies Recalls Torrent Suite Dx Software Due to Incorrect Positive Results
FDA (Devices) · 2019-10-30
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