FDA Medical Device Recalls (openFDA)
Life Technologies Holdings Pte Ltd: 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
- Recall number
- Z-0188-2020
- Recalling firm
- Life Technologies Holdings Pte Ltd
- 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
- Status
- Terminated
- Initiated
- 2019-09-26
- Posted
- not on file
- Terminated
- 2021-11-23
- Reason
- 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
- Root cause
- Software design
- Action
- 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
- Quantity
- total of Ion+vela +chassis =400 units
- Distribution
- states : AZ, CA, CO, CT, FL, GA, IN, MA, MD, NC, NJ, NM, NY, OR, TX, VA, WA OUS: South Korea, ITALY, China, Japan, Singapore, Germany, TAIWAN, Poland
- Lot, serial or model codes
- The field action is associated with the software available on the PGM Dx instrument, therefore no lot code is applicable for this part type
- 510(k) numbers
- ["K170299"]
- PMA numbers
- not on file
- Product code
- PFF
- Firm FEI
- 3003673482
- Firm city
- Singapore
- Firm state
- not on file
- Firm country
- Singapore
Where this comes from
- Register
- FDA Medical Device Recalls (openFDA)
- Publisher
- U.S. Food and Drug Administration (openFDA)
- File
- device-recall-0001-of-0001.json.zip
- sha256
- b87518bfe2e8
- Size
- 288210821 bytes
- Published
- 2026-09-28
- Read
- 2026-09-29T08:25:23.626Z
- Source file
- Source file retained · verify
- Refresh due
- 2026-10-06
Unless otherwise noted, the content, data, documentation, code, and related materials on openFDA is public domain and made available with a Creative Commons CC0 1.0 Universal dedication.
Cite as
FDA Medical Device Recalls (openFDA) (U.S. Food and Drug Administration (openFDA)), device-recall-0001-of-0001.json.zip, sha256 b87518bfe2e8, published 2026-09-28