FDA Device recall Z-0171-2019
Gibco MEM Non-Essential Amino Acids Solution (100X) (SKU 11140050), for In-Vitro Diagnostic Use
- FDA Device
- Class II
- terminated
- Published 2018-10-24
On 2018-10-24 the FDA classified a Class II recall of Gibco MEM Non-Essential Amino Acids Solution (100X) (SKU 11140050), for In-Vitro Diagnostic Use by Life Technologies, citing leaky bottles due to a defect in the bottle cap compromising the sterility of the product.
Read the official FDA Device notice
| Agency | FDA Device |
|---|---|
| Recall number | Z-0171-2019 |
| Classification | Class II |
| Status | terminated |
| Initiated | 2018-08-24 |
| Published | 2018-10-24 |
| Last updated | 2026-09-13 11:54 UTC |
| Company | Life Technologies |
| Distribution | US |
Product
Gibco MEM Non-Essential Amino Acids Solution (100X) (SKU 11140050), for In-Vitro Diagnostic Use
Reason
Leaky bottles due to a defect in the bottle cap compromising the sterility of the product
Identifiers
| code_info | Lot# 1986670 Exp.Date 30-Dec-2019. Lot# 1995631 Exp. Date 31-Jan-2020. UDI: 10190302001731 |
|---|
Status history
No status changes recorded since RecallRadar first saw this recall on 2026-09-13 11:54 UTC. Current status: terminated.
Source
Official record: https://api.fda.gov/device/enforcement.json?search=recall_number:%22Z-0171-2019%22
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