EliA GBM Wells, Material Number 14551401, for Phadia 250, 2500, and 5000. In vitro diagnostic
Summary
The FDA issued a Class II for EliA GBM Wells, Material Number 14551401, for Phadia 250, 2500, and 5000. In vit by Phadia Ab. Reason: Complaints that specific samples produced false positive EliA GBM results. A positive signal was present when these samples were tested for coating-so.
Details
Source
Device Recall
External ID
Z-0783-2024
Action Date
2024-01-31
Status
Ongoing
Category
device
Product Description
EliA GBM Wells, Material Number 14551401, for Phadia 250, 2500, and 5000. In vitro diagnostic
Lot/Code Info: UDI-DI: 07333066010670; All Lots.
Quantity Affected: 124,928 kits
Reason for Recall
Complaints that specific samples produced false positive EliA GBM results. A positive signal was present when these samples were tested for coating-solution reactivity using EliA wells without antigen.
Distribution
US Nationwide.
Type: Voluntary: Firm initiated
Recall Initiated: 2023-05-24
Company
Uppsala, 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 144 device recalls issued in the same week, part of 403 device-related FDA actions this month.
Phadia Ab has 5 FDA actions in our database, including 1 recall and 4 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 (Phadia Ab) or your retailer for a refund or replacement. If you experienced adverse effects, report them to the FDA via MedWatch.
How often does Phadia Ab have FDA actions?
Phadia Ab has 5 FDA actions in our database, including 1 recall and 4 device clearances.
Where can I find the official FDA record?
The official record is available on FDA.gov. Search for "Z-0783-2024" on FDA.gov for the full record. You can also use the openFDA API to query this record programmatically.
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