Gibco MEM Non-Essential Amino Acids Solution — Class II medical device recall Z-0171-2019
Terminated recall by Life Technologies, Corp., reported 2018-10-24, distributed nationwide. Leaky bottles due to a defect in the bottle cap compromising the sterility of the product
| Recall number | Z-0171-2019 |
|---|---|
| Product type | Medical device |
| Classification | Class II |
| Status | Terminated |
| Voluntary or mandated | Voluntary |
| Recalling firm | Life Technologies, Corp., Grand Island, NY, United States |
| Recall initiated | 2018-08-24 |
| Classified | 2018-10-17 |
| Reported by FDA | 2018-10-24 |
| Terminated | 2020-04-29 |
| Distributed | Nationwide (US) |
| Countries outside the US | AR, AU, CA, CN, GB, HK, IN, JP, KR, MX, NL, NZ, SG, TW |
| Quantity | 1,329 units |
| Reason classes | sterility, packaging |
| UPC / GTIN / UDI-DI | 10190302001731 |
| Lot numbers | 1986670, 1995631 |
| Expiration dates | 2019-12-30, 2020-01-31 |
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
Machine access
This record, with every extracted code, the verbatim FDA record and provenance, is available from the recall API: GET https://api.data.aroqon.com/v1/recalls/Z-0171-2019. Look up any UPC, UDI, NDC or lot with /v1/recalls/lookup?code=…. API docs · free and paid keys.
Source: U.S. Food and Drug Administration enforcement report via openFDA (CC0). Structured by Data Foundry (recall-structuring@2); last changed 2026-09-26. Not affiliated with or endorsed by FDA. Not medical or legal advice.