Reported Oct 30, 2019 · Terminated
Torrent Suite Dx Software Version 5.6.4 Catalog Number:A33178 OEM Customer software: Sentosa SQ Suite Software v5.6.20…
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 5.6.4
- Catalog NumberA33178
- OEM Customer softwareSentosa SQ Suite Software v5.6.20
- UDI(01)10190302005654 (11)000000 (10)5.6.4 (240)A33178
- 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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