Gibco CTS OpTmizer T Cell Expansion Serum Free Medium — Class II medical device recall Z-2542-2018
Terminated recall by Life Technologies, Corp., reported 2018-08-01, distributed in CA, CO, CT, FL, GA, MA, MD, PA…. It has been determined that the fill port tube seal integrity was compromised during the manufacture of the pr
| Recall number | Z-2542-2018 |
|---|---|
| Product type | Medical device |
| Classification | Class II |
| Status | Terminated |
| Voluntary or mandated | Voluntary |
| Recalling firm | Life Technologies, Corp., Grand Island, NY, United States |
| Recall initiated | 2018-05-10 |
| Classified | 2018-07-25 |
| Reported by FDA | 2018-08-01 |
| Terminated | 2020-05-05 |
| Distributed | CA, CO, CT, FL, GA, MA, MD, PA, RI, UT, WA |
| Countries outside the US | CA, CH, FR, GB, JP, KR, NL |
| Reason classes | microbial contamination, sterility, packaging |
| Pathogens | mold |
| Lot numbers | 1921298, 1921302 |
| Model numbers | A1022103, A1048503 |
Product
Gibco CTS OpTmizer T Cell Expansion Serum Free Medium, bag format, Model Numbers A1048503 and A1022103. Tissue and cell culture medium.
Reason for recall
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.
Machine access
This record, with every extracted code, the verbatim FDA record and provenance, is available from the recall API: GET https://api.data.aroqon.com/v1/recalls/Z-2542-2018. Look up any UPC, UDI, NDC or lot with /v1/recalls/lookup?code=…. API docs · free and paid keys.
Source: U.S. Food and Drug Administration enforcement report via openFDA (CC0). Structured by Data Foundry (recall-structuring@2); last changed 2026-09-26. Not affiliated with or endorsed by FDA. Not medical or legal advice.