Food, drugs, devices › Life Technologies Corporation
Device recall: Oncomine Dx Target Test DNA Control-IVD for detection of DNA and RNA isolated from non-small cell lung cancer (NSCLC) tu
FDA enforcement event 85203 is a device recall by Life Technologies Corporation of Frederick, MD, initiated 16 Mar 2020 and classified Class II, with 4 product records.
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. 93% of the 916 device enforcement events initiated in 2020 carry the same class.
Status: Terminated, terminated 26 Mar 2021. 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
"Extended Expiration Date prior to clearance"
Distribution
"US Nationwide distribution."
Product records
| Recall number | Product | Quantity | Class | Status | Report date |
|---|---|---|---|---|---|
| Z-1704-2020 | Oncomine Dx Target Test DNA Control-IVD for detection of DNA and RNA isolated from non-small cell lung cancer (NSCLC) tumor specimens, Catalog Number: A32442. | 66 units | Class II | Terminated | 22 Apr 2020 |
| Z-1705-2020 | Oncomine Dx Target Test RNA Control- IVD for detection of DNA and RNA isolated from non-small cell lung cancer (NSCLC) tumor specimens, Catalog Number: A32443 | 66 units | Class II | Terminated | 22 Apr 2020 |
| Z-1706-2020 | Oncomine Dx Target Test RNA/DNA Panel- IVD for detection of DNA and RNA isolated from non-small cell lung cancer (NSCLC) tumor specimens, Catalog Number: A32441 | 35 units | Class II | Terminated | 22 Apr 2020 |
| Z-1707-2020 | Ion Torrent Dx No Template Control Kit- IVD for detection of DNA and RNA isolated from non-small cell lung cancer (NSCLC) tumor specimens Catalog Number: A32444 | 79 units | Class II | Terminated | 22 Apr 2020 |
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 |
| 11 Jun 2019 | StemPro¿ MSC SFM CTS" | Device | Class II | 2 |
| 8 Feb 2018 | Oncomine Dx Target Test, (Model No. A32451), Oncomine Dx Target RNA/DNA Panel (Model No. A32441). A qualitative In Vitro | Device | Class II | 1 |
| 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: "Extended Expiration Date prior to clearance"
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: "US Nationwide distribution."
Is the recall still ongoing?
FDA lists the status as Terminated; the termination date is 26 Mar 2021. "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.