FDA Device recall Z-2924-2020
Pancreatic Amylase AY3855 batch 480483 Pancreatic Amylase Ethylidene Blocked-pNPG7 Reagent
- FDA Device
- Class II
- terminated
- Published 2020-09-09
On 2020-09-09 the FDA classified a Class II recall of Pancreatic Amylase AY3855 batch 480483 Pancreatic Amylase Ethylidene Blocked-pNPG7 Reagent by Randox Laboratories, citing 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.
Read the official FDA Device notice
| Agency | FDA Device |
|---|---|
| Recall number | Z-2924-2020 |
| Classification | Class II |
| Status | terminated |
| Initiated | 2020-07-10 |
| Published | 2020-09-09 |
| Last updated | 2026-09-13 11:55 UTC |
| Company | Randox Laboratories |
| Distribution | MA, NM, WV |
Product
Pancreatic Amylase AY3855 batch 480483 Pancreatic Amylase Ethylidene Blocked-pNPG7 Reagent
Reason
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.
Identifiers
| code_info | AY3855 GTIN 05055273200614 |
|---|
Status history
No status changes recorded since RecallRadar first saw this recall on 2026-09-13 11:55 UTC. Current status: terminated.
Source
Official record: https://api.fda.gov/device/enforcement.json?search=recall_number:%22Z-2924-2020%22
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