Summary
The FDA issued a Class II for BioPlex 2200 REF 12000670 ToRC IgM Reagent Pack by Bio-Rad Laboratories, Inc.. Reason: Performance concerns for the CMV IgM analyte. Analyte has demonstrated variable elevated background depending on the handling of the reagent pack..
Details
Source
Device Recall
External ID
Z-1096-2022
Action Date
2022-05-25
Status
Ongoing
Category
device
Product Description
BioPlex 2200 REF 12000670 ToRC IgM Reagent Pack
Lot/Code Info: Model/Catalog Number: 12000670 UDI-DI (GTIN) Code: 03610520992715 Lot Number: 301388
Quantity Affected: 348 units
Reason for Recall
Performance concerns for the CMV IgM analyte. Analyte has demonstrated variable elevated background depending on the handling of the reagent pack.
Distribution
Worldwide distribution - U.S. Nationwide distribution in the states of AR, AZ, CA, FL, HI, IA, IL, MI, MN, NE, NY, TN, TX, and WA. The countries of Czech Republic, France, Germany, and Italy.
Type: Voluntary: Firm initiated
Recall Initiated: 2022-04-14
Company
Redmond, WA
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 164 device recalls issued in the same week, part of 403 device-related FDA actions this month.
Bio-Rad Laboratories, Inc. has 12 FDA actions in our database, including 12 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 (Bio-Rad Laboratories, Inc.) or your retailer for a refund or replacement. If you experienced adverse effects, report them to the FDA via MedWatch.
How often does Bio-Rad Laboratories, Inc. have FDA actions?
Bio-Rad Laboratories, Inc. has 12 FDA actions in our database, including 12 recalls and 0 device clearances.
Where can I find the official FDA record?
The official record is available on FDA.gov. Search for "Z-1096-2022" on FDA.gov for the full record. You can also use the openFDA API to query this record programmatically.
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