BioPlex 2200 REF 12000650 SYPH T PACK Syphilis Total & RPR Reagent Pack
Summary
The FDA issued a Class II for BioPlex 2200 REF 12000650 SYPH T PACK Syphilis Total & RPR Reagent Pack by Bio-Rad Laboratories, Inc.. Reason: Due to current concerns related to COVID-19 vaccine interference with the RPR portion of the BioPlex 2200 Syphilis Total & RPR panel, as well as inter.
Details
Source
Device Recall
External ID
Z-0806-2022
Action Date
2022-03-23
Status
Ongoing
Category
device
Product Description
BioPlex 2200 REF 12000650 SYPH T PACK Syphilis Total & RPR Reagent Pack
Lot/Code Info: Catalog Number: 12000650 UDI GTIN Code: 03610520653012 Lot Numbers: 301336
Quantity Affected: 9,426 packs (U.S.)
Reason for Recall
Due to current concerns related to COVID-19 vaccine interference with the RPR portion of the BioPlex 2200 Syphilis Total & RPR panel, as well as intermittent manufacturing challenges to produce RPR reagents that consistently meet stability specifications
Distribution
Worldwide distribution U.S. Nationwide distribution in the states of AK, AL, AZ, CA, CO, CT, FL, GA, HI, IA, IL, IN, KS, KY, LA, MA, ME, MI, MN, MO, MS, NC, ND, NE, NJ, NV, NY, OH, OK, OR, PA, Puerto Rico, RI, SC, SD, TN, TX, UT, VA, WA, WI, and WV. The countries of France, Germany, Italy, Spain, Saudi Arabia, and United Arab Emirates.
Type: Voluntary: Firm initiated
Recall Initiated: 2022-02-08
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 145 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-0806-2022" on FDA.gov for the full record. You can also use the openFDA API to query this record programmatically.
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