Amylase AY3805 batch 480449 Amylase Ethylidene Blocked-pNPG7 Reagent
Reported: September 9, 2020 Initiated: July 10, 2020 #Z-2923-2020
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.
Details
- Recalling Firm
- RANDOX LABORATORIES, LTD.
- Units Affected
- 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 Africa Thailand The Bahamas Turkey UAE UK Vietnam
- Location
- Crumlin Colorado Antrim, N/A
Frequently Asked Questions
What product was recalled? ▼
Amylase AY3805 batch 480449 Amylase Ethylidene Blocked-pNPG7 Reagent. Recalled by RANDOX LABORATORIES, LTD.. Units affected: 1497 units.
Why was this product recalled? ▼
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.
Which agency issued this recall? ▼
This recall was issued by the FDA Devices on September 9, 2020. Severity: Moderate. Recall number: Z-2923-2020.
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