RegWardenFDA facility compliance records
Facility

LIFE TECHNOLOGIES HOLDINGS PTE LTD

1 recall(s) on record — most severe on record: Class II.

Activity by year

FDA actions on record by year2020: 1 recalls20172018201912020202120222023202420252026
  • Recalls (1)

Devices registered here (1)

  • Instrumentation For Clinical Multiplex Test Systems
    Product code NSU (opens in a new tab) · Class II · Clinical Chemistry · 21 CFR 862.2570

Recalls & enforcement

  • Class IITerminated2020-08-06
    COVID-19 Interpretive Software issues that may cause: 1) the risk of invalid or inconclusive tests/false negative and potentially increasing the retesting burden on customers. 2) false positive results due to improper vortexing.

Related

Source: U.S. FDA via openFDA (opens in a new tab) (device registration & enforcement). Data as of 2026-10-06. Verify this facility record at FDA → (opens in a new tab)

Cite this record

RegWarden. “LIFE TECHNOLOGIES HOLDINGS PTE LTD (FEI 3010286073) — FDA facility record.” Compiled from U.S. FDA public records (openFDA; FDA Data Dashboard). Data as of 2026-10-06. https://regwarden.com/facility/3010286073-life-technologies-holdings-pte-ltd/

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