Recall Z-2923-2020 ยท CIJ Saccharogenic, Amylase
RANDOX LABORATORIES, LTD.
Amylase AY3805 batch 480449 Amylase Ethylidene Blocked-pNPG7 Reagent
| Date | Jul 10, 2020 |
| Status | Terminated |
| 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 |
| FDA record | Open on fda.gov |
510(k) clearances named in this recall
| K953211 | AMYLASE (ETHYLIDENE PNGPG7) KIT Randox Laboratories, Ltd., Jun 21, 1996 |