Z-2099-2021 Class II Terminated
FDA device recall Z-2099-2021 was initiated by Randox Laboratories Ltd. on May 10, 2021 and is designated Class II. Reason for recall: Standard packed within NEFA kit has been assigned incorrectly. Calibrating with the incorrect value will cause a positive shift of up to +8% with both quality controls and patient samples The recall status is terminated (terminated November 10, 2021). Affected quantity: 71 kits US.
Recall Details
- Product Type
- Devices
- Report Date
- July 28, 2021
- Initiation Date
- May 10, 2021
- Termination Date
- November 10, 2021
- Voluntary/Mandated
- Voluntary: Firm initiated
- Product Quantity
- 71 kits US
Product Description
NEFA CAL (Non-Esterified Fatty Acids)- IVD Standard for measurement of NEFA Catalog Number: FA115
Reason for Recall
Standard packed within NEFA kit has been assigned incorrectly. Calibrating with the incorrect value will cause a positive shift of up to +8% with both quality controls and patient samples
Distribution Pattern
US Nationwide Distribution in the states of AR, CA, CT, NY, OH, PA, TN, and TX
Code Information
Batch Number: 544642 Exp. Date: 28th Nov 2022 GTIN: 05055273203066