Grand Island, NY, United States
Life Technologies Corporation recalls
9 recalls recorded since 2018, most recently on 7 February 2024. 1 is listed as ongoing. Status and classification are as published by the FDA.
Recalls9
Ongoing (FDA)1
Terminated or completed8
Class I (FDA)0
Ongoing Class II Medical devices
- Recall started
- 7 February 2024
- Reason
- 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
- Distribution
- US Nationwide distribution in the states of CA, IN, NC OR, TN.
- Initiated
- Voluntary: Firm initiated
- Recall number
- Z-1426-2024
- Torrent Suite Dx Software versions 5.14 and earlier used in connection with Ion PGM DX Systems-IVD intended for targeted sequencing of human genomic DNA (gDNA) from peripheral whole-blood samples and DNA and RNA extracte
Terminated Class II Medical devices
- Recall started
- 6 August 2020
- Terminated
- 5 May 2022
- Reason
- 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.
- Distribution
- US: AL, AR, AZ, CA, CO, CT, DE, FL, GA, HI, IA, ID, IL, IN, KS, KY, LA, MA, MD, MI, MN, MO, MS, NC, NH, NJ, NM, NY, NV, OH, OK, OR, PA, PR, RI, SC, SD, TN, TX, UT, VA, VT, WA, WI, and WV. OUS: Afghanistan, Algeria, Argentina, Australia, Austria, Azerbaijan, Bahrain, Bangladesh, Belarus, Botswana,
- Initiated
- Voluntary: Firm initiated
- Recall numbers
- Z-2979-2020, Z-2978-2020
- The TaqPath RT-PCR COVID-19 Kit with Applied Biosystem's COVID-19 Interpretive Software v2.0 or v2.2 (used with the QuantStudio Real-Time PCR platforms), includes the assays and controls for a multiplex real-time RT-PCR
- The TaqPath RT-PCR COVID-19 Kit with Applied Biosystem's COVID-19 Interpretive Software v1.2 for 7500 RTPCR instruments, includes the assays and controls for a multiplex real-time RT-PCR test for the qualitative detectio
Terminated Class II Medical devices
- Recall started
- 16 March 2020
- Terminated
- 26 March 2021
- Reason
- Extended Expiration Date prior to clearance
- Distribution
- US Nationwide distribution.
- Initiated
- Voluntary: Firm initiated
- Recall numbers
- Z-1704-2020, Z-1706-2020, Z-1707-2020, Z-1705-2020
- 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.
- 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
- 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
- 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
Terminated Class II Medical devices
- Recall started
- 11 June 2019
- Terminated
- 4 June 2020
- Reason
- Component was not tested by the supplier for adventitious agents
- Distribution
- StemPro¿ MSC SFM CTSTM distributed to the following states in the USA: AL, CA, CO, CT, DC, FL, GA, IA, IL, KS, MA, MD, MN, NC, NE, NJ, NY,OH, OR, PA, RI, TX, UT, VA, WA, WI. StemPro¿ MSC SFM CTSTM distributed Internationally to the following countries: Australia, Belgium, Brazil, Canada, Chile,
- Initiated
- Voluntary: Firm initiated
- Recall numbers
- Z-0274-2020, Z-0275-2020
- StemPro¿ MSC SFM CTS"
- CTSTM Essential 8 Medium
Terminated Class II Medical devices
- Recall started
- 24 August 2018
- Terminated
- 29 April 2020
- Reason
- Leaky bottles due to a defect in the bottle cap compromising the sterility of the product
- Distribution
- Nationwide: Foreign: Argentina Australia Canada China Great Britain Hong Kong India Japan Mexico Netherlands New Zealand Singapore South Korea Taiwan
- Initiated
- Voluntary: Firm initiated
- Recall numbers
- Z-0171-2019, Z-0174-2019, Z-0172-2019, Z-0173-2019
- Gibco MEM Non-Essential Amino Acids Solution (100X) (SKU 11140050), for In-Vitro Diagnostic Use
- Gibco GlutaMAX Supplement, for In-Vitro Diagnostic Use SKU 35050061
- Gibco DPBS, calcium, magnesium, for In-Vitro Diagnostic Use SKU 14040141
- Gibco Sodium Pyruvate (100 mM) SKU 11360070, for In-Vitro Diagnostic Use
Terminated Class II Medical devices
- Recall started
- 10 May 2018
- Terminated
- 5 May 2020
- Reason
- 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, leaked media.
- Distribution
- Worldwide distribution. US states: CA, CO, CT, FL, GA, MA, MD, PA, RI, UT, and WA., Canada, France, Great Britain, Japan, Korea, Netherlands, and Switzerland.
- Initiated
- Voluntary: Firm initiated
- Recall numbers
- Z-2543-2018, Z-2545-2018, Z-2542-2018, Z-2544-2018, Z-2547-2018, Z-2546-2018
- GIBCO CTS AIM V Serum-Free Media (SFM), Model Number 0870112BK. Tissue and cell culture medium.
- Gibco Dulbecco's Modified Eagle Medium (DMEM), high glucose, Model Number 11965175. Tissue and cell culture medium.
- Gibco CTS OpTmizer T Cell Expansion Serum Free Medium, bag format, Model Numbers A1048503 and A1022103. Tissue and cell culture medium.
- Gibco Dulbecco's Modified Eagle Medium (DMEM), high glucose, pyruvate, Model Number 11995115. Tissue and cell culture medium.
- Gibco Dulbecco's Modified Eagle Medium (DMEM), high glucose, pyruvate, Model Number 11995123. Tissue and cell culture medium.
- Gibco RPMI 1640 Medium, Model Number 61870150. Tissue and cell culture medium.
Terminated Class II Medical devices
- Recall started
- 8 February 2018
- Terminated
- 12 May 2020
- Reason
- 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.
- Initiated
- Voluntary: Firm initiated
- Recall number
- 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.
Terminated Class II Medical devices
- Recall started
- 7 February 2018
- Terminated
- 8 May 2019
- Reason
- 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)
- Distribution
- MI, CA, IL, TX, SC, NY, MN, DE, NJ, WA , OR, IN, MA, DE, FL, PA
- Initiated
- Voluntary: Firm initiated
- Recall number
- Z-1388-2018
- Human Fetal Hemoglobin (HBF-1) FITC Conjugate
Terminated Class II Medical devices
- Recall started
- 4 December 2017
- Terminated
- 10 November 2020
- Reason
- 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.
- Distribution
- US Distribution to the states of: AZ, CA, NC, TX, and VA.
- Initiated
- Voluntary: Firm initiated
- Recall number
- Z-1279-2018
- Oncomine Dx Target Test User Guides and Assay Definition File, Model: A32461; UDI: (01)10190302006071(11)170911(10)1.8(240)A32461 The Oncomine Dx Target Test is a qualitative in vitro diagnostic test that uses target
A terminated FDA recall means the FDA has determined that all reasonable efforts to remove or correct the product have been made. What statuses mean.