Life Technologies Recalls Torrent Suite Dx Software for Incorrect Results
Life Technologies is recalling Torrent Suite Dx software because it may incorrectly display positive results for specific 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 4/5 (Severe).
The hazard poses a serious risk of illness, injury, or structural failure. Stop using the product immediately and contact the manufacturer for a refund or repair.
Our severity reasoning: The agency classified this as a Class II recall. Under the severity rubric, FDA Class II recalls are assigned a score of 4 (Severe), particularly when involving significant injury or property damage reports, or in the absence of explicit 'no injury' statements that would lower the score to 3.
Plain-English summary
Life Technologies Holdings Pte Ltd is recalling Torrent Suite Dx analysis software, a component of the Ion PGM Dx Instrument System. The software is identified by Catalog Number A29225 and is associated with the OEM Customer Software Sentosa SQ Suite Software v5.6.9.
The recall is due to a defect where the software 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 issue affects the software available on the PGM Dx instrument. The recall involves a total of 400 units, comprising Ion+vela and chassis components.
The affected software was distributed in the United States to the states of Arizona, California, Colorado, Connecticut, Florida, Georgia, Indiana, Massachusetts, Maryland, North Carolina, New Jersey, New Mexico, New York, Oregon, Texas, Virginia, and Washington. It was also distributed internationally to South Korea, Italy, China, Japan, Singapore, Germany, Taiwan, and Poland. Because this is a software field action, no lot code is applicable for this part type.
The recalled product
- Product
- Torrent Suite Dx Software Version (IUO) 5.2 Catalog Number: A29225 OEM Customer Software: Sentosa SQ Suite Software v5.6.9
- 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
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See all →- SevereTorrent Suite Dx Software Recalled for Incorrect Positive Variant Results
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- HighLife Technologies Recalls Torrent Suite Dx Software Due to Incorrect Positive Results
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