Severity
Moderate
ModerateClass IITerminated
FDA Devices recall · Reported October 30, 2019
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
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 det…
Compiled from official public sources by the editorial team.
Verify with FDA Devices →
Life Technologies Holdings Pte Ltd recalled Torrent Suite Dx Software Version 5.8 Catalog Number:A36601 and A36602 OEM Customer sof… - a moderate-severity action.
Torrent Suite Dx Software Version 5.8 Catalog Number:A36601 and A36602 OEM Customer sof… was recalled by Life Technologies Holdings Pte Ltd in October 30, 2019. Reason: Torrent SuiteTM Dx analysis software, a component of the Ion PGM Dx Instrument System, incorrectly displays a…. Check the official notice for the remedy. Verify recall #Z-0188-2020 with the FDA Devices before acting.
The recall
Life Technologies Holdings Pte Ltd issued this moderate-severity FDA Devices recall-Torrent SuiteTM Dx analysis software, a component of the Ion PGM Dx Instrument System, incorrectly displays a….
- Moderate
- severity level
- Class II
- classification
- October 30, 2019
- reported
Sourced from official FDA Devices enforcement records. Verify recall #Z-0188-2020 with the agency before acting. Full product description, hazard, remedy, and related recalls are below.
Recall Insight
This FDA Devices action (record #Z-0188-2020) was formally reported on October 30, 2019, with the manufacturer initiating the action on September 26, 2019. It is classified under Moderate severity (Class II), with a current status of Terminated. Life Technologies Holdings Pte Ltd is listed as the recalling firm, operating out of Singapore. Federal records list the affected scope as total of Ion+vela +chassis =400 units.
The documented reason for this recall is: 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 c… Distribution data in the federal record shows the product reached: 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. Distribution scope directly affects the consumer exposure window and determines whether a recall remains regional or escalates into a nationwide advisory.
Within the same product category the archive holds 6 closely related recalls, 3 from FDA Devices - clustering in a narrow category often points to a systemic quality-control or supplier issue rather than a one-off defect. Always verify the recall number against the official agency record before acting.
Medical Devices recalls over time
Where this recall sits in its category - 40,322 medical devices recalls on record
Of 101,704 recalls in the database, 24,878 are high severity, 72,426 moderate, and 4,400 low. This recall is classified moderate severity.
Counts reflect market size and reporting activity, not inherent danger, we do not rank products by risk from raw recall volume.
Affected scope
total of Ion+vela +chassis =400 units
Related Recalls
6
3 from same agency
Product description
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
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
Recall Profile
| Attribute | Value |
|---|---|
| Agency | U.S. Food and Drug Administration |
| Severity class | Moderate (Class II) |
| Status | Terminated |
| Recall number | Z-0188-2020 |
| Date reported | October 30, 2019 |
| Date initiated | September 26, 2019 |
| Recalling firm | Life Technologies Holdings Pte Ltd |
| Firm location | Singapore |
| Affected scope | 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 |
Profile values are sourced directly from the official FDA Devices enforcement record. Source: U.S. Food and Drug Administration.
What to do with this recall
Match your product against the recall record, then act on the agency remedy.
- Check the recall number (Z-0188-2020) and product description against the item you own. Search the archive
- Confirm the current status with FDA Devices before acting, recall details can be updated.
- Follow the documented remedy (refund, replacement, repair, or disposal) rather than general advice. What to do next
This page summarizes the official FDA Devices record for research and awareness; it is not legal, medical, or safety advice. Verify with the issuing agency before acting.
Frequently Asked Questions
What product was recalled? ▼
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. Recalled by Life Technologies Holdings Pte Ltd. Units affected: total of Ion+vela +chassis =400 units.
Why was this product 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
Which agency issued this recall? ▼
This recall was issued by the FDA Devices on October 30, 2019. Severity: Moderate. Recall number: Z-0188-2020.
Where was the recalled product distributed? ▼
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.
How do I check if my product is affected by a recall? ▼
Check the product description and recall number (Z-0188-2020) against your product. Visit the official FDA Devices website for the most current information. You can also use our Recall Checker tool to search by product name or brand.
Should I stop using a recalled medication or medical device? ▼
Do not stop using a recalled medication or device without consulting your healthcare provider first, as abruptly discontinuing treatment could pose its own health risks. Your doctor can advise on alternatives or whether the recall applies to your specific product lot. Check the recall number and lot information against your product packaging.
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Every figure on PlainRecalls is rendered directly from official FDA, CPSC and NHTSA recall records, no number is typed in by an editor. This recall: FDA Devices, reported October 30, 2019. Severity classes follow each agency's own taxonomy (FDA Class I/II/III; CPSC and NHTSA by hazard type), and related-recall context is computed across the full archive. See our editorial standards & corrections policy, the methodology behind these numbers, or report a data error. Data current as of July 2026.