Life Technologies Recalls Gibco CTS OpTmizer T Cell Expansion Medium
Life Technologies is recalling Gibco CTS OpTmizer T Cell Expansion Serum Free Medium due to compromised fill port tube seals that may allow mold growth.
What this means for you
Real risk of harm even if no illness or injury has been reported yet. Stop using the product and follow the agency's guidance.
Our severity reasoning: The recall is classified as FDA Class II. The hazard involves a risk of harm (mold growth in cell culture medium) where injury has not yet been reported, fitting the criteria for a High severity score.
Plain-English summary
Life Technologies, Corp. is recalling Gibco CTS OpTmizer T Cell Expansion Serum Free Medium, bag format, Model Numbers A1048503 and A1022103. The affected product is a tissue and cell culture medium. The recall involves specific lots, including 1921298, 1921302, 1902977, 1902981, 1904379, 1904381, 1912383, 1915452, 1921291, and 1925754.
The recall was initiated because the fill port tube seal integrity was compromised during the manufacture of the product lot. This defect may cause media to leak out of the primary sterile packaging into the outer non-sterile dust cover packaging. Subsequently, mold may grow in the pooled, leaked media.
The product was distributed worldwide, including in the United States (CA, CO, CT, FL, GA, MA, MD, PA, RI, UT, and WA) and in Canada, France, Great Britain, Japan, Korea, the Netherlands, and Switzerland. As of June 21, 2019, 6,304 units were involved in the recall. Users should check their inventory for the affected lot numbers and stop using the product if it matches the recalled lots.
The recalled product
- Product
- Gibco CTS OpTmizer T Cell Expansion Serum Free Medium, bag format, Model Numbers A1048503 and A1022103. Tissue and cell culture medium.
- Manufacturer
- Life Technologies, Corp.
Is your product affected?
Check your packaging against the codes below. If any of them match, the product is part of this recall.
Lot numbers (1)
- Lot: 1921298
Distribution
Part of a larger recall action
This product is one of 6 recalled by Life Technologies, Corp. under a single FDA (Devices) recall action. The agency files each product separately, so the size of the action is not visible from this page alone.
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