Cystatin C Calibrator - In vitro diagnostic (IVD) use in the calibration of the Randox Cystatin C assay on automated ana
Summary
The FDA issued a Class II for Cystatin C Calibrator - In vitro diagnostic (IVD) use in the calibration of the by Randox Laboratories Ltd.. Reason: Cystatin C Calibrator Series CVS 2699, is running with a negative bias compared to other methods.
Details
Source
Device Recall
External ID
Z-1369-2024
Action Date
2024-04-03
Status
Ongoing
Category
device
Product Description
Cystatin C Calibrator - In vitro diagnostic (IVD) use in the calibration of the Randox Cystatin C assay on automated analysers Catalog Number: CVS 2699
Lot/Code Info: GTIN: 05055273207439 (1) Batch 600957 Lot 1378CY - 1382CY (2) Batch 621809, 621815 Lot 1403CY - 1407CY (3) Batch 650533 Lot 1414CY - 1418CY
Quantity Affected: 666 units
Reason for Recall
Cystatin C Calibrator Series CVS 2699, is running with a negative bias compared to other methods
Distribution
US Nationwide distribution in the states of CA, IN.
Type: Voluntary: Firm initiated
Recall Initiated: 2024-02-14
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 163 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-1369-2024" on FDA.gov for the full record. You can also use the openFDA API to query this record programmatically.
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