SEROLOGY ToRCH lgM 2022 POSITIVE CONTROLI Intended for use with in vitro assays for determination of IgM antibodies to C
Summary
The FDA issued a Class III for SEROLOGY ToRCH lgM 2022 POSITIVE CONTROLI Intended for use with in vitro assays by Randox Laboratories Ltd.. Reason: A decrease in the reactivity of HSV Type 1/2 lgM in the Serology ToRCH lgM Positive Control when tested on the DiaSorin Liaison XL..
Details
Source
Device Recall
External ID
Z-0624-2024
Action Date
2024-01-10
Status
Ongoing
Category
device
Product Description
SEROLOGY ToRCH lgM 2022 POSITIVE CONTROLI Intended for use with in vitro assays for determination of IgM antibodies to Cytomegalovirus (CMV), IgM antibodies to Rubella Virus, IgM antibodies to Toxoplasma gondii, IgM antibodies to Herpes Simplex Virus Type 1 and 2. Catalog Number: SR10349
Lot/Code Info: GTIN: 05055273216424 Bath/Lot Number: 157SR
Quantity Affected: 1 unit
Reason for Recall
A decrease in the reactivity of HSV Type 1/2 lgM in the Serology ToRCH lgM Positive Control when tested on the DiaSorin Liaison XL.
Distribution
NY, WV
Type: Voluntary: Firm initiated
Recall Initiated: 2023-11-06
Company
Crumlin (North), N/A
Context & Analysis
This is a Class III recall. Class III recalls involve products unlikely to cause adverse health consequences, but that violate FDA regulations.
This was one of 84 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 III recall?
A Class III recall involves products that are unlikely to cause adverse health effects but violate FDA labeling or manufacturing regulations.
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-0624-2024" on FDA.gov for the full record. You can also use the openFDA API to query this record programmatically.
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