Randox Amylase Reagent Recall: Performance Issues Before Sept 2020 Expiry
Randox recalls specific batches of Amylase Ethylidene Blocked-pNPG7 Reagent due to performance failures before expiry. Affected units may not function correctly as intended.
Lower-risk 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.
Contact the company
What happened, in plain English
Randox is recalling certain batches of Amylase Ethylidene Blocked-pNPG7 Reagent because they failed to meet performance standards before their Sept 2020 expiry date. This means the reagent might not work properly in lab tests. Read more at govinfonow.com/recall/64735-randox-amylase-reagent-recall-performance-issues-before-sept-2020-expiry.
Source Summary by GovInfoNow · govinfonow.com/recall/64735-randox-amylase-reagent-recall-performance-issues-before-sept-2020-expiry · Updated August 19, 2026 · FDA enforcement record: FDA #Z-2923-2020
Cite this page
“Randox Amylase Reagent Recall: Performance Issues Before Sept 2020 Expiry.” GovInfoNow, updated August 19, 2026. https://govinfonow.com/recall/64735-randox-amylase-reagent-recall-performance-issues-before-sept-2020-expiry. Based on FDA recall #Z-2923-2020 (https://api.fda.gov/device/enforcement.json?search=recall_number:%22Z-2923-2020%22&limit=1).
Why it’s dangerous
The reagent failed to meet performance claims before its expiry date, meaning it might not function correctly in laboratory tests. This could lead to inaccurate test results if used without proper validation.
Who’s affected
Lab users who purchased the specific batch numbers (AY3805 batch 480449 or AY3855 batch 480483) before September 28, 2020, are affected. Those using the reagent for medical testing are most at risk.
How to tell if you have this one
Check for the batch numbers: AY3805 batch 480449 or AY3855 batch 480483. The product is sold under the GTIN 05055273200607.
- Brand
Randox- Product
RANDOX LABORATORIES, LTD. recalls Amylase AY3805 batch 480449 Amylase Ethylidene Blocked-pNPG7 Reagent- Category
Medical device
All 2 products in this recall
FDA lists each product line separately under one recall event. Check your product description, lot or code numbers against each row. Every row shares the hazard and remedy on this page.
- Classification
Class II- Status
Terminated- 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
| Recall number | Product, codes & lots | Quantity |
|---|---|---|
| Z-2923-2020 | Amylase AY3805 batch 480449 Amylase Ethylidene Blocked-pNPG7 Reagent; AY3805 GTIN 05055273200607 | 1497 units |
| Z-2924-2020 | Pancreatic Amylase AY3855 batch 480483 Pancreatic Amylase Ethylidene Blocked-pNPG7 Reagent; AY3855 GTIN 05055273200614 | 105 units |
What to do — step by step
Check Batch Number
Look for the batch numbers AY3805 480449 or AY3855 480483 on the product label.
Where it went and when
Where it was distributed
Distributed in 3 states, and outside the U.S.
FDA 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…” States read from FDA’s own wording; “not listed” means the notice does not name it.
States: Massachusetts, New Mexico, West Virginia.
Recall timeline
FDA terminated this recall 11 months after the firm started it.
- Firm started the recall
- FDA classified it Class II
- Published in FDA’s Enforcement Report
- FDA terminated the recall
Dates from the agency record only; steps without a date are left out.
Similar recalls
Latest medical device recalls
Keep exploring
Where this comes from
The facts (hazard, remedy, dates, manufacturer) are pulled from the official FDA recall record. The plain-language summary and step-by-step checklist are written by GovInfoNow to make the official notice easier to act on — they don’t replace it.
- Official source: FDA Recall #Z-2923-2020 (July 10, 2020) — FDA publishes no per-recall page; this is the official machine-readable enforcement record. Search FDA recalls for Z-2923-2020 to see it in context.
- Plain-language summary written by qwen3:4b on August 19, 2026, from the official record above. Not reviewed by a person — if it conflicts with the FDA notice, the notice is correct. Report an error on this page.
- GovInfoNow is an independent service and is not a government agency. We republish official FDA recall data; we don’t issue, amend or administer recalls.