Gibco CTS OpTmizer T Cell Expansion Serum Free Medium recall: Sterility Concern
Gibco CTS OpTmizer T Cell Expansion Serum Free Medium, bag format, Model Numbers A1048503 and A1022103. Tissue and cell culture medium.
Why was Gibco CTS OpTmizer T Cell Expansion Serum Free Medium recalled?
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.
What should I do if I have this product?
Review the official FDA enforcement record for current instructions.
What to do with a recalled product: refunds, receipts, safe disposal and how to report a problem.
Is my product affected?
Compare the item in your hand with every identifier below from the official FDA record. Only products that match the listed product and lot, UPC or model codes are part of this recall.
Which lot codes, UPCs or models are affected?
Lot: 1921298, 1921302 Updated as of 6/14/19: 1902977 1902981 1904379 1904381 1912383 1915452 1921291 1925754 1921291 1921298 1921302 1925754
- Product
- Gibco CTS OpTmizer T Cell Expansion Serum Free Medium, bag format, Model Numbers A1048503 and A1022103. Tissue and cell culture medium.
- Recalling firm
- Life Technologies, Corp.
- Quantity
- Updated as of 6/21/19: 6304 units
- Distribution
- 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.
- Recall date
- August 1, 2018
- Classification
- Class II
- Status
- Terminated
- Agency
- FDA (device)