Facility

Life Technologies Corporation

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

Key facts

9recalls · worst Class II

—inspections in our data

—warning letters in our data

Recalls are listed for the parent company: openFDA recall records do not name a facility. How we attribute records

FDA Establishment Identifier (FEI)	1317268
Establishment type	Repack or Relabel Medical Device; Manufacture Medical Device; Manufacture Medical Device for Another Party (Contract Manufacturer)
Location	3175 STALEY ROAD GRAND ISLAND, NY, US 14072
Registration status	Active · expires 2026
Parent company	Life Technologies Corporation (owner-operator 9915045)
Brand names	AmnioMAX C-100 Basal Medium(17001082); AmnioMAX-II Complete Medium(11269016); KaryoMAX Colcemid Solution in PBS(15212012); PB-MAX Karyotyping Medium(12557021); PB-MAX Karyotyping Medium(12557013); MarrowMAX Bone Marrow Medium(12260014); MarrowMAX Bone Marrow Medium(12260001); AmnioMAX C-100 Basal Medium(17001074); AmnioMAX C-100 Supplement(12556015); KaryoMAX Colcemid Solution in HBSS(15210040); AmnioMAX C-100 Supplement(12556023)

Activity by year

Recalls (9)

Devices registered here (1)

Kit, Culture, Chromosome
Product code KIQ (opens in a new tab) · Class I · Hematology · 21 CFR 864.2260

Recalls & enforcement

Class IIOngoing2024-02-07
Torrent Suite Dx Software versions 5.14 and earlier used in connection with Ion PGM DX Systems exploitation of the vulnerability by a threat actor may allow them to alter settings, configurations, software, or data on the instrument
Class IITerminated2020-03-16
Extended Expiration Date prior to clearance
Class IITerminated2019-06-11
Component was not tested by the supplier for adventitious agents
Class IITerminated2018-08-24
Leaky bottles due to a defect in the bottle cap compromising the sterility of the product
Class IITerminated2018-05-10
It has been determined that the fill port tube seal integrity was compromised during the manufacture of the product lot. This may cause media to leak out of the primary sterile packaging into outer non-sterile dust cover packaging, and subsequently mold may grow in the pooled, le…
Class IITerminated2018-02-08
The lower concentration of the RNA panel could cause a NO CALL or FALSE NEGATIVE for the reporting of ROS1 fusion. If a physician relies on a false negative result, crizotinib could be improperly excluded from the patient's treatment regimen.
Class IITerminated2018-02-07
Three lots of Human Fetal Hemoglobin FITC Conjugate are displaying high background and unusual bright staining in the controls and patient samples which could potentially lead to erroneous results (i.e. false positives)
Class IITerminated2017-12-04
The Oncomine Dx Target Test may report erroneous results when used off-label for samples other than non-small cell lung cancer (NSCLC) tumor specimens.
Class IITerminated2013-05-13
Firm received complaints that HSV-2 primers failed to amplify HSV-2 DNA.

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 Corporation (FEI 1317268) — FDA facility record.” Compiled from U.S. FDA public records (openFDA; FDA Data Dashboard). Data as of 2026-10-06. https://regwarden.com/facility/1317268-life-technologies-corporation/

Not open yet

Alerts for Life Technologies Corporation

Watchlist alerts will email you when FDA publishes a new recall, inspection classification, or warning letter for a facility you follow. They aren't open to the public yet — leave your email and we'll tell you when they are.

Planned

Want a one-page facility brief?

A single-page summary of this facility's registration and recall history for diligence. Not selling it yet — register interest and we'll follow up.