Device product
Gibco MEM Non-Essential Amino Acids Solution (100X) (SKU 11140050), for In-Vitro Diagnostic Use
Z-0171-2019
Product summary
- Event
- Event 81052
- Status
- Terminated
- Classification
- Class II
- Quantity
- 1329 units
- Official record key
device-enforcement:Z-0171-2019
Official wording
Reason: Leaky bottles due to a defect in the bottle cap compromising the sterility of the product
Code information: Lot# 1986670 Exp.Date 30-Dec-2019. Lot# 1995631 Exp. Date 31-Jan-2020. UDI: 10190302001731
Distribution pattern: Nationwide: Foreign: Argentina Australia Canada China Great Britain Hong Kong India Japan Mexico Netherlands New Zealand Singapore South Korea Taiwan
Derived failure modes
-
Unknown
Leaky bottles due to a defect in the bottle cap compromising the sterility of the product