RANDOX CHOL-cholesterol (total) test system intended to measure cholesterol in plasma and serum REF: CH200
Summary
The FDA issued a Class II for RANDOX CHOL-cholesterol (total) test system intended to measure cholesterol in p by Randox Laboratories Ltd.. Reason: When calibrating using the standard provided in the kit, the change in absorbance is lower than expected generating internal quality control results h.
Details
Source
Device Recall
External ID
Z-0328-2022
Action Date
2021-12-08
Status
Terminated
Category
device
Product Description
RANDOX CHOL-cholesterol (total) test system intended to measure cholesterol in plasma and serum REF: CH200
Lot/Code Info: Lot Numbers/Exp Date: 559344 28th June 2022; 572730 28th July 2023. GTIN: 05055273201130
Quantity Affected: 15 kits
Reason for Recall
When calibrating using the standard provided in the kit, the change in absorbance is lower than expected generating internal quality control results high outside range
Distribution
US Nationwide distribution in the states of GA, OR, PA ,WA, West Virginia.
Type: Voluntary: Firm initiated
Recall Initiated: 2021-11-01
Company
Crumlin (North)
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 131 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-0328-2022" on FDA.gov for the full record. You can also use the openFDA API to query this record programmatically.
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