Amylase AY3805 batch 480449 Amylase Ethylidene Blocked-pNPG7 Reagent — Class II medical device recall Z-2923-2020
Terminated recall by RANDOX LABORATORIES, LTD., reported 2020-09-09, distributed in MA, NM, WV. Amylase AY3805 batch 480449 and Pancreatic Amylase AY3855 batch 480483 have failed to meet the quoted performa
| Recall number | Z-2923-2020 |
|---|---|
| Product type | Medical device |
| Classification | Class II |
| Status | Terminated |
| Voluntary or mandated | Voluntary |
| Recalling firm | RANDOX LABORATORIES, LTD., Crumlin Colorado Antrim, N/A, United Kingdom |
| Recall initiated | 2020-07-10 |
| Classified | 2020-08-28 |
| Reported by FDA | 2020-09-09 |
| Terminated | 2021-06-17 |
| Distributed | MA, NM, WV |
| Countries outside the US | AE, BO, BR, BS, CO, CR, CY, EG, FR, GB, GR, IN, IQ, IT, JO, KE, LT, MX, NG, NP, PE, PH, PK, PL, PT, QA, RO, RU, TH, TR, VN, ZA |
| Quantity | 1,497 units |
| UPC / GTIN / UDI-DI | 05055273200607 |
| Lot numbers | 480449 |
Product
Amylase AY3805 batch 480449 Amylase Ethylidene Blocked-pNPG7 Reagent
Reason for recall
Amylase AY3805 batch 480449 and Pancreatic Amylase AY3855 batch 480483 have failed to meet the quoted performance claims prior to expiry on 28th Sept 2020.
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-2923-2020. 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.