Liquid Assayed Specific Protein Control Level 2- In vitro diagnostic use, in the quality control of serum on clinical c
Summary
The FDA issued a Class II for Liquid Assayed Specific Protein Control Level 2- In vitro diagnostic use, in th by Randox Laboratories Ltd.. Reason: Concentration of Rheumatoid Factor has decreased in Specific Protein Control Level 1-3 causing delay in reporting results due to Quality Controls runn.
Details
Source
Device Recall
External ID
Z-0904-2023
Action Date
2023-01-11
Status
Ongoing
Category
device
Product Description
Liquid Assayed Specific Protein Control Level 2- In vitro diagnostic use, in the quality control of serum on clinical chemistry and immunoassay systems Catalog Number: PS2683
Lot/Code Info: GTIN: 05055273204902 Lot Number/Exp. Date: 585LPC 28thJun 23; 601LPC 28th Nov 23; 612LPC 28th Sep 24
Quantity Affected: 115 units
Reason for Recall
Concentration of Rheumatoid Factor has decreased in Specific Protein Control Level 1-3 causing delay in reporting results due to Quality Controls running low outside range
Distribution
US Nationwide distribution in the states of CA, FL, OH,ME, MO, NC, NJ, PA, TN.
Type: Voluntary: Firm initiated
Recall Initiated: 2022-11-22
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 162 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-0904-2023" on FDA.gov for the full record. You can also use the openFDA API to query this record programmatically.
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