Z-2924-2020Class II

Pancreatic Amylase AY3855 batch 480483 Pancreatic Amylase Ethylidene Blocked-pNPG7 Reagent

Name: Z-2924-2020 Pancreatic Amylase AY3855 batch 480483 Pancreatic Amylase Ethylidene Blocked-pNPG7 Reagent
Creator: Randox Laboratories, Ltd.
Published: 2020-07-10
License: https://open.fda.gov/license/

Randox Laboratories, Limited / initiated 2020-07-10 / Terminated

FDA source

RANDOX LABORATORIES, LTD. began a recall of Pancreatic Amylase AY3855 batch 480483 Pancreatic Amylase Ethylidene Blocked-pNPG7 Reagent on 2020-07-10. FDA classified it as Class II and gives the reason as "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". As of 2026-09-10, the recall status on record is Terminated.

Recall record

Recall number: Z-2924-2020
Classification: Class II
Status: Terminated
Initiated: 2020-07-10
Posted: 2020-08-29
Terminated: 2021-06-17
Recalling firm: Randox Laboratories, Limited
Product: Pancreatic Amylase AY3855 batch 480483 Pancreatic Amylase Ethylidene Blocked-pNPG7 Reagent
Product code: JFJ Catalytic Methods, Amylase
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.
FDA 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 in commerce: 105 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
Product codes and lots: AY3855 GTIN 05055273200614

Enforcement reports

One row per recalled product line

FDA enforcement reports joined to recall event Z-2924-2020
Recall number	Class	Status	Voluntary or mandated	Report date	Classified
Z-2923-2020	Class II	Terminated	Voluntary: Firm initiated	2020-09-09	2020-08-28
Z-2924-2020	Class II	Terminated	Voluntary: Firm initiated	2020-09-09	2020-08-28

Product code JFJ

K971825Class IIPancreatic Amylase, Ethylidene Blocked-Pnpg7 Enzyme Colorimetric TestRandox Laboratories, Ltd. / cleared 1997-07-24

MDM coverage of this record lists here, newest first.

About this record

Sourced from the FDA device recall database and the FDA enforcement reports, both ingested from openFDA. The recall record supplies the product, the reason and the product code; the enforcement report supplies the classification. The two datasets are exported by FDA on different days, and the date above is the older of the two, so nothing on this page is newer than it says.

MDM adds the root cause tag, derived from FDA’s own root cause text, and the cross-links to the product code, the clearances named on the record and MDM coverage. Where a recall has not been joined to an enforcement report, no classification is shown.

Data as of 2026-09-30, the FDA export date for this dataset. Page last changed 2026-09-05. View this recall on fda.gov (opens on fda.gov)