FDA recall Z-0171-2019

Life Technologies, Corp. · Class II · device

Product

Gibco MEM Non-Essential Amino Acids Solution (100X) (SKU 11140050), for In-Vitro Diagnostic Use

Reason for recall

Leaky bottles due to a defect in the bottle cap compromising the sterility of the product

Distribution

Nationwide: Foreign: Argentina Australia Canada China Great Britain Hong Kong India Japan Mexico Netherlands New Zealand Singapore South Korea Taiwan

Key facts

Status
Terminated
Initiation date
2018-08-24
Report date
2018-10-24
Termination date
2020-04-29
Voluntary/Mandated
Voluntary: Firm initiated
Location
Grand Island, NY, United States

Primary source

https://www.accessdata.fda.gov/scripts/ires/index.cfm?Product=Z-0171-2019