Reported Oct 30, 2019 · Terminated
Torrent Suite Dx Software Version 5.8 Catalog Number:A36601 and A36602 OEM Customer software: Torrent Suite Dx T430…
Life Technologies Holdings Pte Ltd.
Moderate riskThis product could cause temporary or reversible health problems — stop using it.What you should do
Stop using the affected lot and contact the recalling firm for the return or refund process. Check the FDA enforcement report for lot-level detail.
Firm contact: Life Technologies Holdings Pte Ltd · Blk 33 Marsiling Ind Estate Road 3 · Singapore · N/A
Is this the product you have?
- Torrent Suite Dx Software Version 5.8
- Catalog NumberA36601
- and A36602 OEM Customer softwareTorrent Suite Dx T430 Software v5.0
- DARUI DR-SEQ 800 Software UDI(01)10190302014090 (11)000000(10)5.8 (240)A36601
- Lot codes and dates
- The field action is associated with the software available on the PGM Dx instrument, therefore no lot code is applicable for this part type
- Amount recalled
- total of Ion+vela +chassis =400 units
This recall covers 4 products
The agency filed one notice per product. You are reading one of them; the other 3 are below.
Where it was sold
Why it was recalled
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
This product could cause temporary or reversible health problems — stop using it.
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The guide adds the identifying codes laid out for scanning, symptoms to watch for, a timeline, and news coverage of this recall.
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