# FDA recall Z-2924-2020

> **RANDOX LABORATORIES, LTD.** · Class II · device recall initiated 2020-07-10.

## Product

Pancreatic Amylase AY3855 batch 480483  Pancreatic 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.

## Distribution

New Mexico, Massachusetts,  WV.    Foreign distribution to Bolivia  BOSNIA AND HERZEGOVINA  Brazil   Colombia  Costa Rica  Cyprus  Egypt  France  Greece  Grenada  India  Iraq   Italy   Jordan  Kazakhstan  Kenya  Lithuania  Mauritius  Nepal  Nigeria  Pakistan   Peru  Philippines  Poland  Portugal  Qatar  Romania   Russia   South Africa   Thailand   The Bahamas   Turkey  UAE  UK  Vietnam

## Key facts

- **Recall number:** Z-2924-2020
- **Recalling firm:** RANDOX LABORATORIES, LTD.
- **Classification:** Class II
- **Product type:** device
- **Status:** Terminated
- **Initiation date:** 2020-07-10
- **Report date:** 2020-09-09
- **Termination date:** 2021-06-17

- **Voluntary/Mandated:** Voluntary: Firm initiated
- **Location:** Crumlin Colorado Antrim, N/A, United Kingdom

## Primary source

FDA Enforcement Reports: https://www.accessdata.fda.gov/scripts/ires/index.cfm?Product=Z-2924-2020

## Citation

> AI Analytics. FDA recall Z-2924-2020. Retrieved 2026-06-02 from https://api.ai-analytics.org/recall/Z-2924-2020. Source: US FDA. Licensed CC0.

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