Life Technologies Recalls Torrent Suite Dx Software Due to Incorrect Positive Results
Life Technologies is recalling Torrent Suite Dx software because it may incorrectly display positive results for clinical variants.
What this means for you
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 could lead to incorrect clinical results (false positives), representing a risk of harm where injury has not yet been reported, consistent with the High severity criteria.
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 A31774 and is associated with the OEM Customer Software Sentosa SQ Suite Software v5.6.15.
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, and no lot code is applicable for this part type.
The affected units include a total of 400 Ion+vela +chassis units. Distribution includes the United States states of AZ, CA, CO, CT, FL, GA, IN, MA, MD, NC, NJ, NM, NY, OR, TX, VA, and WA, as well as South Korea, Italy, China, Japan, Singapore, Germany, Taiwan, and Poland.
The recalled product
- Product
- Torrent Suite Dx Software Version (IUO) 5.4 Catalog Number: A31774 OEM Customer Software: Sentosa SQ Suite Software v5.6.15
- Manufacturer
- Life Technologies Holdings Pte Ltd
- Category
- Medical Device — Software
- Hazard
- 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
- HighTorrent 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
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