CLASS II Device recall · Reported 30 Oct 2019 · FDA Enforcement Report

Torrent Suite Dx recalled by Life Technologies Holdings Pte

Life Technologies Holdings Pte is recalling Torrent Suite Dx, distributed in 17 states. The recall was initiated on 26 Sep 2019 and the FDA has classified it as Class II.

Check your package

Lot, batch or date codesThe field action is associated with the software available on the PGM Dx instrument, therefore no lot code is applicable for this part type

Quantity recalledtotal of Ion+vela +chassis =400 units

Stop using the device if the notice says to, and contact the manufacturer or your healthcare provider for the correction or replacement.

Recall details

Recall number: Z-0188-2020
FDA event ID: 83786
Recalling firm: Life Technologies Holdings Pte, Singapore
Classification: Class II
Status: Terminated
Recall initiated: 26 Sep 2019
FDA classified: 23 Oct 2019
Reported: 30 Oct 2019
Type: Voluntary: Firm initiated
Customers notified by: Letter
Reason category: Device Malfunction
Device type: Medical Software

Timeline

26 Sep 2019	Recall initiated by company
23 Oct 2019	Classified by FDA	+27 days
30 Oct 2019	Published in enforcement report	+7 days

Companies usually start a recall weeks before the FDA classifies and publishes it; the gap above is that lag.

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

Device recalls are issued when a component, software or design fault could cause the device to fail or give wrong readings. Many are corrections applied in the field rather than physical returns.

Product as listed by the FDA

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

Where it was distributed

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

Arizona California Colorado Connecticut Florida Georgia Indiana Massachusetts Maryland North Carolina New Jersey New Mexico New York Oregon Texas Virginia Washington

Questions about this recall

Why was it recalled?

Which lots are affected?

The field action is associated with the software available on the PGM Dx instrument, therefore no lot code is applicable for this part type

Where was it sold?

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

What should I do if I have it?

Stop using the device if the notice says to, and contact the manufacturer or your healthcare provider for the correction or replacement.

What does Class II mean?

Class II means the product may cause temporary or medically reversible health problems, or the probability of serious harm is remote.

Read the official FDA notice · Source record retrieved 26 Sep 2026. The FDA describes openFDA data as unvalidated; the official notice takes precedence. This page reports the record and gives no medical advice.

Other products in this recall event

3 other products · FDA event 83786

Reported	Class	Recall	Company	Reason	Where
30 Oct 2019	CLASS II	Torrent Suite Dx recalled by Life Technologies Holdings Pte	Life Technologies Holdings Pte	Device Malfunction	17 states
30 Oct 2019	CLASS II	Torrent Suite Dx recalled by Life Technologies Holdings Pte	Life Technologies Holdings Pte	Device Malfunction	17 states
30 Oct 2019	CLASS II	Torrent Suite Dx recalled by Life Technologies Holdings Pte	Life Technologies Holdings Pte	Device Malfunction	17 states

More recalls from Life Technologies Holdings Pte

All 4

Reported	Class	Recall	Company	Reason	Where
30 Oct 2019Device	CLASS II	Torrent Suite Dx recalled by Life Technologies Holdings Pte	Life Technologies Holdings Pte	Device Malfunction	17 states
30 Oct 2019Device	CLASS II	Torrent Suite Dx recalled by Life Technologies Holdings Pte	Life Technologies Holdings Pte	Device Malfunction	17 states
30 Oct 2019Device	CLASS II	Torrent Suite Dx recalled by Life Technologies Holdings Pte	Life Technologies Holdings Pte	Device Malfunction	17 states

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