Z-0188-2020Class II

Torrent Suite Dx Software Version 5.8 Catalog Number:A36601 and A36602 OEM Customer software: Torrent Suite...

Name: Z-0188-2020 Torrent Suite Dx Software Version 5.8 Catalog Number:A36601 and A36602 OEM Customer software: Torrent Suite...
Creator: Life Technologies Holdings Pte Ltd
Published: 2019-09-26
License: https://open.fda.gov/license/

Life Technologies Holdings Pte Ltd. / initiated 2019-09-26 / Terminated / root cause: software

FDA source

Life Technologies Holdings Pte Ltd began a recall of 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... on 2019-09-26. FDA classified it as Class II and gives the reason as "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...". As of 2026-09-10, the recall status on record is Terminated, and MDM tags the root cause as software.

Recall record

Recall number: Z-0188-2020
Classification: Class II
Status: Terminated
Initiated: 2019-09-26
Posted: 2019-10-23
Terminated: 2021-11-23
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
Product code: PFF High Throughput Dna Sequence Analyzer
Reason for recall: 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 tag: software
FDA 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 [email protected]. If you have any technical questions or concerns, please contact Technical Support at 800-955-6288 option 4 or [email protected]
Quantity in commerce: 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
Product codes and lots: The field action is associated with the software available on the PGM Dx instrument, therefore no lot code is applicable for this part type

Enforcement reports

One row per recalled product line

FDA enforcement reports joined to recall event Z-0188-2020
Recall number	Class	Status	Voluntary or mandated	Report date	Classified
Z-0185-2020	Class II	Terminated	Voluntary: Firm initiated	2019-10-30	2019-10-23
Z-0186-2020	Class II	Terminated	Voluntary: Firm initiated	2019-10-30	2019-10-23
Z-0187-2020	Class II	Terminated	Voluntary: Firm initiated	2019-10-30	2019-10-23
Z-0188-2020	Class II	Terminated	Voluntary: Firm initiated	2019-10-30	2019-10-23

Product code PFF

K170299Class IIIon PGM Dx SystemLife Technologies Corporation / cleared 2017-06-22

MDM coverage of this record lists here, newest first.

About this record

Sourced from the FDA device recall database and the FDA enforcement reports, both ingested from openFDA. The recall record supplies the product, the reason and the product code; the enforcement report supplies the classification. The two datasets are exported by FDA on different days, and the date above is the older of the two, so nothing on this page is newer than it says.

MDM adds the root cause tag, derived from FDA’s own root cause text, and the cross-links to the product code, the clearances named on the record and MDM coverage. Where a recall has not been joined to an enforcement report, no classification is shown.

Data as of 2026-09-30, the FDA export date for this dataset. Page last changed 2026-09-05. View this recall on fda.gov (opens on fda.gov)