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Terminated

Amylase AY3805 batch 480449 Amylase Ethylidene Blocked-pNPG7 Reagent

FDA Recall Z-2923-2020 · Posted None

Recalling FirmRANDOX LABORATORIES, LTD.
Recall StatusTerminated
Product CodeCIJ
Date Initiated2020-07-10
Date Terminated2021-06-17
Product Quantity1497 units

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.

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

Root Cause

Under Investigation by firm

Distribution Pattern

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

Related FDA 510(k) Records

Devices referenced by this recall via K-numbers.

K953211AMYLASE (ETHYLIDENE PNGPG7) KITRandox Laboratories, Ltd. · 1996-06-21

Official Source

View FDA Recall →

Source: FDA Enforcement Report / Recall database. Always confirm against the official FDA record.

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