FDA Device recall Z-2542-2018
Gibco CTS OpTmizer T Cell Expansion Serum Free Medium, bag format, Model Numbers A1048503 and A1022103
- FDA Device
- Class II
- terminated
- Published 2018-08-01
On 2018-08-01 the FDA classified a Class II recall of Gibco CTS OpTmizer T Cell Expansion Serum Free Medium, bag format, Model Numbers A1048503 and A1022103 by Life Technologies, citing 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 pa….
Read the official FDA Device notice
| Agency | FDA Device |
|---|---|
| Recall number | Z-2542-2018 |
| Classification | Class II |
| Status | terminated |
| Initiated | 2018-05-10 |
| Published | 2018-08-01 |
| Last updated | 2026-09-13 11:54 UTC |
| Company | Life Technologies |
| Distribution | CA, CO, CT, FL, GA, MA, MD, PA, RI, UT, WA |
Product
Gibco CTS OpTmizer T Cell Expansion Serum Free Medium, bag format, Model Numbers A1048503 and A1022103. Tissue and cell culture medium.
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.
Identifiers
| code_info | Lot: 1921298, 1921302 Updated as of 6/14/19: 1902977 1902981 1904379 1904381 1912383 1915452 1921291 1925754 1921291 1921298 1921302 1925754 |
|---|
Status history
No status changes recorded since RecallRadar first saw this recall on 2026-09-13 11:54 UTC. Current status: terminated.
Source
Official record: https://api.fda.gov/device/enforcement.json?search=recall_number:%22Z-2542-2018%22
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