Amylase AY3805 batch 480449 recallZ-2923-2020 · Randox Laboratories, Ltd. · initiated Jul 10, 2020
Terminated
Is my device affected?
- Compare the model, catalog and lot or serial numbers on your device or its packaging with the code information below. A recall usually covers only specific models or lots.
- If yours is listed, follow the instructions from Randox Laboratories, Ltd. or your healthcare provider. The company's action is summarized under what the company is doing.
- Do not stop using a prescribed or implanted device on your own — talk to your healthcare provider first.
Where to find your model and lot numbers · What recall classes and statuses mean
Why it was recalled
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.
FDA root cause category: Under Investigation by firm
What the company is doing
The consumers were sent a letter via email dated July 10, 2020. This notice instructs customers to The distributors and customers will be instructed to: -Discontinue use of batches listed above immediately -Review your reagent inventory of these products and assess your laboratories needs for replacements. Proof of remaining kits will be required. -Discuss the contents of this notice with your Medical Director. -Complete and return the response form
Recall details
- Recall number
- Z-2923-2020
- Status
- Terminated
- Initiated by the company
- Jul 10, 2020
- Recalling firm
- Randox Laboratories, Ltd.
- Quantity
- 1497 units
- Product code
- CIJ
- FDA submissions
- K953211
- 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
Product description
Amylase AY3805 batch 480449 Amylase Ethylidene Blocked-pNPG7 Reagent
Code information (models, lots, serial numbers)
AY3805 GTIN 05055273200607
Devices named in this recall
1 device in the FDA device registry whose identifier appears in the recall's code information.
- AMY AY3805Randox Laboratories Limited · Saccharogenic, Amylase1 recall0 reports
Other products in the same recall event
The FDA groups related products into one recall event (event 86114).
- Z-2924-2020 · TerminatedPancreatic Amylase AY3855 batch 480483 Pancreatic Amylase Ethylidene Blocked-pNPG7 Reagent
Sources and updates
- Recall record: FDA Medical Device Recalls, file dated Oct 16, 2026 · View the FDA recall notice ↗
- Devices: FDA GUDID, file dated Oct 13, 2026. Devices are linked when their identifier (with a valid check digit) appears in the recall's code information.
- Page last rebuilt: Oct 16, 2026. Text above is shown as published by the FDA.
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