Recall Z-2924-2020
Randox Laboratories, Ltd. · initiated July 10, 2020
Class II – products that might cause a temporary health problem or pose a slight threat of a serious nature
Product
Pancreatic Amylase AY3855 batch 480483 Pancreatic Amylase Ethylidene Blocked-pNPG7 Reagent
Codes / lots: AY3855 GTIN 05055273200614
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: Under Investigation by firm
Action taken
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
Details
- Recall number
- Z-2924-2020
- Initiated
- July 10, 2020
- Terminated
- June 17, 2021
- Product code
- JFJ – Catalytic Methods, Amylase
- Quantity
- 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
- Recalling firm
- Randox Laboratories, Ltd., Crumlin Antrim, Colorado
Other products in the same recall event
| Recall | Product | Initiated |
|---|---|---|
| Z-2923-2020 Class II | Amylase AY3805 batch 480449 Amylase Ethylidene Blocked-pNPG7 ReagentAmylase AY3805 batch 480449 and Pancreatic Amylase AY3855 batch 480483 have failed to meet the quoted… | 07/10/2020Terminated |