FDA Medical Device Recalls (openFDA)
RANDOX LABORATORIES, LTD.: Amylase AY3805 batch 480449 Amylase Ethylidene Blocked-pNPG7 Reagent
- Recall number
- Z-2923-2020
- Recalling firm
- RANDOX LABORATORIES, LTD.
- Product
- Amylase AY3805 batch 480449 Amylase Ethylidene Blocked-pNPG7 Reagent
- Status
- Terminated
- Initiated
- 2020-07-10
- Posted
- not on file
- Terminated
- 2021-06-17
- 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.
- Root cause
- Under Investigation by firm
- Action
- 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
- Quantity
- 1497 units
- 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
- Lot, serial or model codes
- AY3805 GTIN 05055273200607
- 510(k) numbers
- ["K953211"]
- PMA numbers
- not on file
- Product code
- CIJ
- Firm FEI
- 3006697287
- Firm city
- Crumlin Antrim
- Firm state
- Colorado
- Firm country
- United Kingdom
Where this comes from
- Register
- FDA Medical Device Recalls (openFDA)
- Publisher
- U.S. Food and Drug Administration (openFDA)
- File
- device-recall-0001-of-0001.json.zip
- sha256
- b87518bfe2e8
- Size
- 288210821 bytes
- Published
- 2026-09-28
- Read
- 2026-09-29T08:25:23.626Z
- Source file
- Source file retained · verify
- Refresh due
- 2026-10-06
Unless otherwise noted, the content, data, documentation, code, and related materials on openFDA is public domain and made available with a Creative Commons CC0 1.0 Universal dedication.
Cite as
FDA Medical Device Recalls (openFDA) (U.S. Food and Drug Administration (openFDA)), device-recall-0001-of-0001.json.zip, sha256 b87518bfe2e8, published 2026-09-28