Life Technologies Holdings Pte Ltd Blk Torrent Suite Dx Software Version (IUO) 5.2 Catalog Number: A29225 OEM Customer Software: Sentosa SQ Suite Software v5.6.9 Recall
Check Your Product
According to the U.S. Food and Drug Administration (FDA)
Product
Torrent Suite Dx Software Version (IUO) 5.2 Catalog Number: A29225 OEM Customer Software: Sentosa SQ Suite Software v5.6.9
Brand
Life Technologies Holdings Pte Ltd Blk
Lot Codes / Batch Numbers
The field action is associated with the software available on the PGM Dx instrument, therefore no lot code is applicable for this part type
Products Sold
The field action is associated with the software available on the PGM Dx instrument, therefore no lot code is applicable for this part type
Life Technologies Holdings Pte Ltd Blk is recalling Torrent Suite Dx Software Version (IUO) 5.2 Catalog Number: A29225 OEM Customer Software: Sentosa due to Torrent SuiteTM Dx analysis software, a component of the Ion PGM Dx Instrument System, incorrectly displays a positive result when a different analyti. Based on FDA medical device recall database.
Summary derived from FDA notice
Reason for Recall
As stated by FDA
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
Recommended Action
Per FDA guidance
1. Notify all PGM Dx users in your facility of this issue. 2. Require that the Test_Report.pdf file be used for reporting results for all future sample tests. 3. Require that the Test_Report.pdf file be used to confirm ALL positive call results. For sample result reporting that use the Test_Report.pdf file and NOT the Target_Summary.tab file, the results are valid, and no further action is needed. For sample result reporting that use the Target_Summary.tab file on the Torrent SuiteTM Dx software versions indicated above, customers MUST review ALL results obtained using the Target_Summary.tab file against the results shown in the Test_Report.pdf file to identify any occurrences of possible false positive reporting. 4. If you have shared reports using results from the Target_Summary.tab file, outside of your facility, you MUST notify those customers or facilities to take the required action. 5. Please complete the following Customer Response Sheet and submit sheet, along with this letter, by emailing a scanned copy to nitesh.patel@thermofisher.com. If you have any technical questions or concerns, please contact Technical Support at 800-955-6288 option 4 or techsupport@thermofisher.com
Verify this information on the official source
For complete details and official instructions, check the U.S. Food and Drug Administration (FDA) directly.
View official FDA recall noticeDistribution
As reported by FDA
AZ, CA, CO, CT, FL, GA, IN, MD, MA, NJ, NM, NY, NC, OR, TX, VA, WA
Page updated: Jan 10, 2026