FDA-Device2018-08-01Class II
Gibco CTS OpTmizer T Cell Expansion Serum Free Medium, bag format, Model Numbers A1048503 and A1022103. Tissue and cell culture medium.
Life Technologies, Corp.
Hazard
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.
Sold states
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.
Affected count
Updated as of 6/21/19: 6304 units
Manufactured in
3175 Staley Rd, N/A, Grand Island, NY, United States
Products
Gibco CTS OpTmizer T Cell Expansion Serum Free Medium, bag format, Model Numbers A1048503 and A1022103. Tissue and cell culture medium.
Official notice
https://www.accessdata.fda.gov/scripts/ires/index.cfm?Product=Z-2542-2018Don't want to check this manually?
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