Media, Culture, Ex Vivo, Tissue And Cell
Gastroenterology, Urology · 21 CFR 876.5885
Recent MDR events
0 adverse event reports on file
No MDR events on file for this product code.
Event type breakdown
No data available.
Most-reported manufacturers
No data available.
Recalls
7 recall events for this product code
- Life Technologies, Corp.TerminatedJul 25, 2018
Gibco CTS OpTmizer T Cell Expansion Serum Free Medium, bag format, Model Numbers A1048503 and A1022103. Tissue and cell culture medium.
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.
Z-2542-2018 · View FDA record ↗ - Life Technologies, Corp.TerminatedJul 25, 2018
GIBCO CTS AIM V Serum-Free Media (SFM), Model Number 0870112BK. Tissue and cell culture medium.
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.
Z-2543-2018 · View FDA record ↗ - Life Technologies, Corp.TerminatedJul 25, 2018
Gibco Dulbecco's Modified Eagle Medium (DMEM), high glucose, pyruvate, Model Number 11995115. Tissue and cell culture medium.
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.
Z-2544-2018 · View FDA record ↗ - Life Technologies, Corp.TerminatedJul 25, 2018
Gibco Dulbecco's Modified Eagle Medium (DMEM), high glucose, Model Number 11965175. Tissue and cell culture medium.
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.
Z-2545-2018 · View FDA record ↗ - Life Technologies, Corp.TerminatedJul 25, 2018
Gibco RPMI 1640 Medium, Model Number 61870150. Tissue and cell culture medium.
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.
Z-2546-2018 · View FDA record ↗ - Life Technologies, Corp.TerminatedJul 25, 2018
Gibco Dulbecco's Modified Eagle Medium (DMEM), high glucose, pyruvate, Model Number 11995123. Tissue and cell culture medium.
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.
Z-2547-2018 · View FDA record ↗ - Life Technologies CorporationTerminatedUnknown
StemPro MSC SFM CTS"
Component was not tested by the supplier for adventitious agents
Z-0274-2020 · View FDA record ↗
Registered firms
1 firms currently registered for this product code
510(k) clearances
9 clearances for this product code
- Yocon Biology Technology CompanySep 6, 2024
K232543 · MSC SFM
- Duogenic Stemcells CorporationJul 12, 2024
K240247 · MoFi Cell Culture Basal Medium
- Fujifilm Irvine ScientificNov 9, 2023
K231804 · PRIME-XV FreezIS DMSO-Free MD
- Energy Delivery SolutionsSep 20, 2021
K201789 · CT-STOR
- Life Technologies, Inc.Jun 21, 2012
K113566 · OPTMIZER CTS T-CELL EXPANSION SERUM FREE MEDIUM
- Life Technologies CorporationFeb 18, 2011
K103302 · STEMPRO MSC SFM
- Life Technologies CorporationMay 20, 2010
K100616 · KNOCKOUT SR MEDIUM, KNOCKOUT SR XENOFREE MEDIUM MODEL 10828, 12618
- Invitrogen CorporationDec 23, 2002
K022086 · AIM-V (R) MEDIUM, MODEL 087-0112