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U.S. Department of Health and Human Services

Class 2 Device Recall Pancreatic Amylase Ethylidene BlockedpNPG7 Reagent

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 Class 2 Device Recall Pancreatic Amylase Ethylidene BlockedpNPG7 Reagentsee related information
Date Initiated by FirmJuly 10, 2020
Create DateAugust 29, 2020
Recall Status1 Terminated 3 on June 17, 2021
Recall NumberZ-2924-2020
Recall Event ID 86114
510(K)NumberK971825 
Product Classification Catalytic methods, amylase - Product Code JFJ
ProductPancreatic Amylase AY3855 batch 480483 Pancreatic Amylase Ethylidene Blocked-pNPG7 Reagent
Code Information AY3855 GTIN 05055273200614
Recalling Firm/
Manufacturer		 RANDOX LABORATORIES, LTD.
34 Diamond Rd
Crumlin Colorado Antrim United Kingdom
Manufacturer 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 Determined
Cause 2		Under Investigation by firm
ActionThe 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 Commerce105 units
DistributionNew 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
Total Product Life CycleTPLC Device Report
1 A record in this database is created when a firm initiates a correction or removal action. The record is updated if the FDA identifies a violation and classifies the action as a recall, and it is updated for a final time when the recall is terminated. Learn more about medical device recalls.
2 Per FDA policy, recall cause determinations are subject to modification up to the point of termination of the recall.
3 For details about termination of a recall see Code of Federal Regulations (CFR) Title 21 §7.55.
510(K) Database510(K)s with Product Code = JFJ
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