Class 2 Device Recall BioPlex 2200 APLS IgM

• Date Initiated by Firm: February 28, 2023
• Date Posted: May 10, 2023
• Recall Status: Open, Classified
• Recall Number: Z-1572-2023
• Recall Event ID: 91889
• 510(K)Number: K130528
• Product Classification: System, test, anticardiolipin immunological - Product Code MID
• Product: BioPlex 2200 REF 665-2050, APLS IgM Pack, APLS IgM Reagent Pack
• Code Information: Lot Code: 301538; UDI-DI: (00)847865000666
• Recalling Firm/ Manufacturer: Bio-Rad Laboratories, Inc.; 6565 185th Ave Ne; Redmond WA 98052-5039
• For Additional Information Contact: Anna Gralinska-Schram; 510-741-6643
• Manufacturer Reason for Recall: APLS IgM reagent kits were packaged with the incorrect conjugate, which could lead to an increase in false-positive and false-negative results.
• FDA Determined Cause: Under Investigation by firm
• Action: On February 28, 2023, Bio-Rad Laboratories issued an "Urgent: Medical Device Recall" letter to affected consignees. In addition, to informing consignees about the recall, they ask consignees to take the following actions: We are requesting that customers perform quality control using the BioPlex APLS IgM Control Set (Catalog No. 663-2030, UDI GTIN 00847865000642) with each reagent pack ( single pack validation ) of BioPlex 2200 APLS IgM Reagent Pack, Lot No. 301538, until replacement product is provided. If QC fails (controls below or above the acceptable range), please discontinue use of the reagent pack and dispose of it according to local waste management procedures. If the control values are within the acceptable range, the reagent pack may be used and patient results may be released. If you have distributed or transferred this product to any other Bio-Rad customers, or to any other laboratories from your site, please notify those customers of this field action. Please complete the attached Customer Response Form and return it to your local Bio-Rad Technical Support so they can assist you with obtaining replacement reagent packs as needed.
• Quantity in Commerce: 932 Reagent Packs
• Distribution: US Nationwide distribution including in the states of AL, AR, AZ, CA, CT, FL, HI, IL, IN, KS, KY, LA, MI, MO, NC, ND, NE, NJ, NM, NY, OH, OK, PR,SC, TN, TX, UT, VT.
• 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 The manufacturer has initiated the recall and not all products have been corrected or removed. This record will be updated as the status changes.

• 510(K) Database: 510(K)s with Product Code = MID