BioPlex 2200 REF 665-2050, APLS IgM Pack, APLS IgM Reagent Pack

FDA device recall Z-1572-2023 · posted 2023-05-10 · Open, Classified

Recall details

Recalling firm

Bio-Rad Laboratories, Inc.

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.

Action taken

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.

Root cause

Under Investigation by firm

Status

Open, Classified

Product code

MID

Quantity affected

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.

Date initiated

2023-02-28

Date posted

2023-05-10

Location

Redmond, WA

Related 510(k) clearances