NEFA CAL (Non-Esterified Fatty Acids)- IVD Standard for measurement of NEFA Catalog Number: FA115
Summary
The FDA issued a Class II for NEFA CAL (Non-Esterified Fatty Acids)- IVD Standard for measurement of NEFA Cat by Randox Laboratories Ltd.. Reason: Standard packed within NEFA kit has been assigned incorrectly. Calibrating with the incorrect value will cause a positive shift of up to +8% with bot.
Details
Source
Device Recall
External ID
Z-2099-2021
Action Date
2021-07-28
Status
Terminated
Category
device
Product Description
NEFA CAL (Non-Esterified Fatty Acids)- IVD Standard for measurement of NEFA Catalog Number: FA115
Lot/Code Info: Batch Number: 544642 Exp. Date: 28th Nov 2022 GTIN: 05055273203066
Quantity Affected: 71 kits US
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
US Nationwide Distribution in the states of AR, CA, CT, NY, OH, PA, TN, and TX
Type: Voluntary: Firm initiated
Recall Initiated: 2021-05-10
Company
Crumlin (North), N/A
Context & Analysis
This is a Class II recall. Class II recalls indicate that use of or exposure to the product may cause temporary or medically reversible health consequences, or that the probability of serious consequences is remote.
This was one of 191 device recalls issued in the same week, part of 403 device-related FDA actions this month.
Randox Laboratories Ltd. has 39 FDA actions in our database, including 37 recalls and 2 clearances.
Frequently Asked Questions
What is a Class II recall?
A Class II recall means the product may cause temporary or medically reversible adverse health consequences, or the probability of serious adverse consequences is remote. Consumers should discontinue use.
What should I do if I have this product?
Stop using the product. Check the product against the specific lot numbers or identifiers listed in the recall. Contact the manufacturer (Randox Laboratories Ltd.) or your retailer for a refund or replacement. If you experienced adverse effects, report them to the FDA via MedWatch.
How often does Randox Laboratories Ltd. have FDA actions?
Randox Laboratories Ltd. has 39 FDA actions in our database, including 37 recalls and 2 device clearances.
Where can I find the official FDA record?
The official record is available on FDA.gov. Search for "Z-2099-2021" on FDA.gov for the full record. You can also use the openFDA API to query this record programmatically.
Want to know the moment something like this happens?
Get alerts for deviceRelated Actions
MAHURKAR 12 Fr High Pressure Triple Lumen Acute Dialysis Catheter, 24 cm, Straight Extensions, IC Tray REF: 888810200
Covidien LP · 2023-08-23
Sterile Procedural Trays, labeled as the following: a. BREAST AUGMENTATION b. BREAST REDUCTION CDS c. CUH ABDOMINO
MEDLINE INDUSTRIES, LP - Northfield · 2023-02-15
VTC Regular Kit Nephrostomy Catheter System Kit, Material Number REF M001245300; to provide external drainage of the uri
Boston Scientific Corporation · 2024-09-25
EnChroma Safety Glasses with Rx Indoor Universal Lenses: Martinez Cx1 Indoor Rx, SKU: Cx.PC.IN.MTZ.BK.Rx; Summit Indoo
Enchroma Inc · 2024-11-27
Otological Ventilation Tube - T-Tube 9mm - Silicone; Product Code: NZ3309;
Adept Medical Ltd · 2025-01-29