Immunoassay Premium Control Tri Level-In vitro diagnostic use, as assayed quality control material to monitor the accura
Summary
The FDA issued a Class III for Immunoassay Premium Control Tri Level-In vitro diagnostic use, as assayed qualit by Randox Laboratories Ltd.. Reason: Delay in reporting results due to Quality Controls running high outside of range. Target value and range for ACTH in Immunoassay Premium Level 3, IA26.
Details
Source
Device Recall
External ID
Z-2022-2023
Action Date
2023-07-05
Status
Ongoing
Category
device
Product Description
Immunoassay Premium Control Tri Level-In vitro diagnostic use, as assayed quality control material to monitor the accuracy and reproducibility of analytes Catalog Number: IA2633
Lot/Code Info: GTIN: 05055273203837 Batch/Lot Number: 583135 Exp. Date: 28th April 23
Quantity Affected: 30 kits
Reason for Recall
Delay in reporting results due to Quality Controls running high outside of range. Target value and range for ACTH in Immunoassay Premium Level 3, IA2640, lot 2031EC and Immunoassay Premium Control Tri Level kit batch 583135 lot 2031EC has been reassigned on the Roche Cobas e801 due to High recovery outside range
Distribution
CA, IL, VA, WA, WI including PR
Type: Voluntary: Firm initiated
Recall Initiated: 2023-05-04
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 367 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-2022-2023" on FDA.gov for the full record. You can also use the openFDA API to query this record programmatically.
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