Summary
The FDA issued a Class II for Calibration Serum Level 3 CAL2351 by Randox Laboratories Ltd.. Reason: CK Total in Calibration Serum Level 3, CAL2351, is running with a positive bias on RX Series instruments compared to other methods experience a shift .
Details
Source
Device Recall
External ID
Z-0752-2024
Action Date
2024-01-24
Status
Ongoing
Category
device
Product Description
Calibration Serum Level 3 CAL2351
Lot/Code Info: GTIN: 05055273200966 Lot Numbers: 1214UE, 1249UE, 1260UE, 1262UE, 1268UE, 1297UE, 1298UE, 1315UE
Quantity Affected: 269 kits
Reason for Recall
CK Total in Calibration Serum Level 3, CAL2351, is running with a positive bias on RX Series instruments compared to other methods experience a shift in Quality Control and patient sample recovery of up to 13%.
Distribution
US Nationwide and Puerto Rico.
Type: Voluntary: Firm initiated
Recall Initiated: 2023-11-20
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 203 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-0752-2024" on FDA.gov for the full record. You can also use the openFDA API to query this record programmatically.
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