Food, drugs, devices › Life Technologies Corporation
Device recall: Oncomine Dx Target Test, (Model No. A32451), Oncomine Dx Target RNA/DNA Panel (Model No. A32441). A qualitative In Vitro
Life Technologies Corporation (Frederick, MD) initiated this device recall on 8 Feb 2018; FDA lists 1 product record under event 79649, classified Class II.
FDA defines Class II as a situation in which use of or exposure to a violative product may cause temporary or medically reversible adverse health consequences or where the probability of serious adverse health consequences is remote. 92% of the 1,074 device enforcement events initiated in 2018 carry the same class.
Status: Terminated, terminated 12 May 2020. Initiation: voluntary: firm initiated. Life Technologies Corporation has 8 enforcement events on this register, with a median of 1 product record per event.
Recall classification reflects the relative degree of health hazard. Text in quotation marks is FDA's. openFDA export dated 28 Sep 2026.
Recalling firm
Life Technologies Corporation, Frederick, MD.
Reason for recall
"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."
Distribution
"Distributed to states: AZ, CA, NC, TX, and VA."
Product records
| Recall number | Product | Quantity | Class | Status | Report date |
|---|---|---|---|---|---|
| Z-1480-2018 | Oncomine Dx Target Test, (Model No. A32451), Oncomine Dx Target RNA/DNA Panel (Model No. A32441). A qualitative In Vitro Diagnostic test. | 30 | Class II | Terminated | 2 May 2018 |
Context
Other enforcement events for Life Technologies Corporation
| Initiated | Product (first record) | Type | Class | Records |
|---|---|---|---|---|
| 7 Feb 2024 | Torrent Suite Dx Software versions 5.14 and earlier used in connection with Ion PGM DX Systems-IVD intended for targeted | Device | Class II | 1 |
| 6 Aug 2020 | The TaqPath RT-PCR COVID-19 Kit with Applied Biosystem's COVID-19 Interpretive Software v1.2 for 7500 RTPCR instruments, | Device | Class II | 2 |
| 16 Mar 2020 | Oncomine Dx Target Test DNA Control-IVD for detection of DNA and RNA isolated from non-small cell lung cancer (NSCLC) tu | Device | Class II | 4 |
| 11 Jun 2019 | StemPro¿ MSC SFM CTS" | Device | Class II | 2 |
| 7 Feb 2018 | Human Fetal Hemoglobin (HBF-1) FITC Conjugate | Device | Class II | 1 |
| 4 Dec 2017 | Oncomine Dx Target Test User Guides and Assay Definition File, Model: A32461; UDI: (01)10190302006071(11)170911(10)1.8(2 | Device | Class II | 1 |
| 13 May 2013 | HSV 2 Primers, Catalog #18081020. Analyte Specific Reagent. The HSV-2 primer pair is specific for HSV-2 (Herpes Simplex | Device | Class II | 1 |
All 8 events for Life Technologies Corporation
Questions and answers
Why was this device recalled?
FDA's record gives the reason for recall as: "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."
What does Class II mean?
FDA classifies recalls by relative degree of health hazard. Class II is a situation in which use of or exposure to a violative product may cause temporary or medically reversible adverse health consequences or where the probability of serious adverse health consequences is remote.
Where was the product distributed?
FDA's distribution pattern field reads: "Distributed to states: AZ, CA, NC, TX, and VA."
Is the recall still ongoing?
FDA lists the status as Terminated; the termination date is 12 May 2020. "Terminated" means FDA has determined that all reasonable efforts to remove or correct the product have been made.
Where does this data come from?
openFDA enforcement reports (food, drug and device), CC0, export dated 28 Sep 2026. Text in quotation marks is FDA's. The FDA enforcement report linked above is authoritative.
Provenance
Source: openFDA device enforcement reports (CC0), export dated 28 Sep 2026; records grouped by FDA event number. The class shown for the event is the most severe class among its records. Errors in processing are corrected at the next build; see corrections.