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 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 recall is classified as FDA Class II, which corresponds to a Severe severity score (4) under the rubric, particularly given the potential for significant injury or misdiagnosis in a medical device context.
Plain-English summary
Life Technologies Holdings Pte Ltd is recalling Torrent Suite Dx analysis software, version 5.6.4, which is a component of the Ion PGM Dx Instrument System. The recall involves a total of 400 units, including Ion+vela and chassis components.
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 defect could lead to inaccurate diagnostic reporting.
The affected software was distributed in the United States (AZ, CA, CO, CT, FL, GA, IN, MA, MD, NC, NJ, NM, NY, OR, TX, VA, WA) and internationally (South Korea, Italy, China, Japan, Singapore, Germany, Taiwan, Poland). Users should contact the manufacturer for instructions on how to resolve the software issue.
The recalled product
- 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
- 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 →- HighTorrent Suite Dx Software Recalled for Incorrect Positive Variant Results
FDA (Devices) · 2019-10-30
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- HighLife Technologies Recalls Torrent Suite Dx Software Due to Incorrect Positive Results
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