Recall Z-2923-2020— RANDOX LABORATORIES, LTD.
Class II · Terminated
Class II FDA medical device recall by RANDOX LABORATORIES, LTD., initiated 2020-07-10, terminated 2021-06-17. It names one FDA 510(k) clearance: K953211. Product: Amylase AY3805 batch 480449 Amylase Ethylidene Blocked-pNPG7 Reagent. 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..
- Recalling firm
- RANDOX LABORATORIES, LTD.
- Classification
- Class II
- Status
- Terminated
- Initiated
- 2020-07-10
- Terminated
- 2021-06-17
- Firm location
- Crumlin Colorado Antrim, N/A, United Kingdom
510(k) clearances named in this recall
1 on FDA's recordK-numbers as listed on FDA's Recall Enterprise System record for this event (openFDA device/recall k_numbers). The recall may also cover devices cleared under other submissions not named here.
Product description
Amylase AY3805 batch 480449 Amylase Ethylidene Blocked-pNPG7 Reagent
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.
Data sourced from openFDA. This site is unofficial and independent of the FDA.