remel BLOOD AGAR EMB AGAR BIPLATE, REF R02041, QTY 100, for invitro diagnostic use
Summary
The FDA issued a Class II for remel BLOOD AGAR EMB AGAR BIPLATE, REF R02041, QTY 100, for invitro diagnostic u by Remel, Inc. Reason: Product may contain surface and subsurface contamination of Listeria monocytogenes which is typically visible immediately upon removal from the packag.
Details
Source
Device Recall
External ID
Z-1201-2025
Action Date
2025-02-26
Status
Ongoing
Category
device
Product Description
remel BLOOD AGAR EMB AGAR BIPLATE, REF R02041, QTY 100, for invitro diagnostic use
Lot/Code Info: UDI/DI 848838003684, Lot Number 213971, exp. 2025-02-25
Quantity Affected: 316 units
Reason for Recall
Product may contain surface and subsurface contamination of Listeria monocytogenes which is typically visible immediately upon removal from the packaging, appearing on the blood side of the biplate.
Distribution
US Nationwide distribution.
Type: Voluntary: Firm initiated
Recall Initiated: 2025-02-13
Company
Lenexa, KS
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 167 device recalls issued in the same week, part of 403 device-related FDA actions this month.
Remel, Inc has 25 FDA actions in our database, including 25 recalls.
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 (Remel, Inc) or your retailer for a refund or replacement. If you experienced adverse effects, report them to the FDA via MedWatch.
How often does Remel, Inc have FDA actions?
Remel, Inc has 25 FDA actions in our database, including 25 recalls and 0 device clearances.
Where can I find the official FDA record?
The official record is available on FDA.gov. Search for "Z-1201-2025" on FDA.gov for the full record. You can also use the openFDA API to query this record programmatically.
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