BioPlex 2200 ANA Screen Control Set, REF: 663-1131 incompatible with ANA Screen Reagent Packs/ANA Kits, REF: 665-1150; a
Summary
The FDA issued a Class II for BioPlex 2200 ANA Screen Control Set, REF: 663-1131 incompatible with ANA Screen by Bio-Rad Laboratories, Inc.. Reason: A new lot of ANA screen control and any subsequent control lots are incompatible with older lot numbers of ANA calibrators and ANA reagent packs..
Details
Source
Device Recall
External ID
Z-0082-2022
Action Date
2021-10-20
Status
Terminated
Category
device
Product Description
BioPlex 2200 ANA Screen Control Set, REF: 663-1131 incompatible with ANA Screen Reagent Packs/ANA Kits, REF: 665-1150; and ANA Screen Calibrator Sets, REF: 663-1101
Lot/Code Info: REF: 663-1131, Lot: 51765, Expiration: 03/05/2021, and any subsequent lots incompatible with: REF: 665-1150, Lot-Expiration: 300884-11/30/2019, 300907-1/31/2020, 300928-3/31/2020, 300933-4/30/2020; and REF: 663-1101, Lot-Expiration: 50661-11/30/2019, 50726-3/11/2020, 50835-3/27/2020, 50858-5/1/2020
Quantity Affected: 206
Reason for Recall
A new lot of ANA screen control and any subsequent control lots are incompatible with older lot numbers of ANA calibrators and ANA reagent packs.
Distribution
Worldwide distribution - U.S Nationwide distribution including in the states of CA, FL, NJ, IL, NE, TN, IN, TX, LA, WA, MI, MA, MN, OH, HI, MO, PA, CT, UT, SD, NY, AL, PR, OR, MD, KY, NC, AZ, SC, VA, WI, GA, IA, RI, AK, OK, KS, ND, MS, ME, NM, AR and the countries of ES, AE, DE, FR, KR, CN, TW, JP, IL, SG, AU, NZ, HK, IT, CA, PT, GB, NO, CZ, SE, CH, UA, RU, BE, DK.
Type: Voluntary: Firm initiated
Recall Initiated: 2019-11-01
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 174 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-0082-2022" on FDA.gov for the full record. You can also use the openFDA API to query this record programmatically.
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