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U.S. Department of Health and Human Services

Class 2 Device Recall BioPlex 2200 ANA Screen Control Set

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  Class 2 Device Recall BioPlex 2200 ANA Screen Control Set see related information
Date Initiated by Firm November 01, 2019
Create Date October 08, 2021
Recall Status1 Terminated 3 on September 27, 2023
Recall Number Z-0082-2022
Recall Event ID 88652
510(K)Number K113610  K041658  
Product Classification Antinuclear antibody, antigen, control - Product Code LKJ
Product 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
Code Information 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
Recalling Firm/
Manufacturer		 Bio-Rad Laboratories, Inc.
6565 185th Ave Ne
Redmond WA 98052-5039
For Additional Information Contact
425-881-8300
Manufacturer 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.
FDA Determined
Cause 2		 Process control
Action On 11/01/2019, ANA Screen Lot Matching-Compatibility Notice, were mailed to customers. Customers were advised of the following: If you have received the new control material, please ensure that your laboratory is using one of the newer lot numbers of BioPlex ANA calibrators and ANA reagents. Should you have any of the older BioPlex ANA reagent packs and calibrator sets listed below in ITALICS remaining in your inventory or if you have used these lots in combination with the new control, please contact your local Technical Support center. The following telephone number was provided: 510-724-7000.
Quantity in Commerce 206
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.
Total Product Life Cycle TPLC Device Report
1 A record in this database is created when a firm initiates a correction or removal action. The record is updated if the FDA identifies a violation and classifies the action as a recall, and it is updated for a final time when the recall is terminated. Learn more about medical device recalls.
2 Per FDA policy, recall cause determinations are subject to modification up to the point of termination of the recall.
3 For details about termination of a recall see Code of Federal Regulations (CFR) Title 21 §7.55.
510(K) Database 510(K)s with Product Code = LKJ and Original Applicant = Bio-Rad Laboratories
510(K)s with Product Code = LKJ and Original Applicant = BIO-RAD LABORATORIES, INC.
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