Liquid Assayed Chemistry Control Premium Plus Level 3, Catalog Number LAE4215
Summary
The FDA issued a Class II for Liquid Assayed Chemistry Control Premium Plus Level 3, Catalog Number LAE4215 by Randox Laboratories Ltd.. Reason: there has been a transcription error in the Instructions for Use (IFU) for the Liquid Assayed Chemistry Control Premium Plus Level 3. For Caeruloplasm.
Details
Source
Device Recall
External ID
Z-2609-2023
Action Date
2023-09-27
Status
Ongoing
Category
device
Product Description
Liquid Assayed Chemistry Control Premium Plus Level 3, Catalog Number LAE4215
Lot/Code Info: UDI-DI: 05055273208986; Lot Number: 1308UE
Quantity Affected: 66 kits
Reason for Recall
there has been a transcription error in the Instructions for Use (IFU) for the Liquid Assayed Chemistry Control Premium Plus Level 3. For Caeruloplasmin, the one and two standard deviation values printed on the sheet are incorrect, which may lead to misreporting patient results. Target and range values are correct, and risk is mitigated; most clinical labs will use the target and range values in clinical practice.
Distribution
US States: GA, OH, OR, PA, TX, VA
Type: Voluntary: Firm initiated
Recall Initiated: 2023-08-03
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 195 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-2609-2023" on FDA.gov for the full record. You can also use the openFDA API to query this record programmatically.
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