FDA Medical Device Recalls (openFDA)
Bio-Rad Laboratories, Inc.: BioPlex 2200 REF 665-2050, APLS IgM Pack, APLS IgM Reagent Pack
- Recall number
- Z-1572-2023
- Recalling firm
- Bio-Rad Laboratories, Inc.
- Product
- BioPlex 2200 REF 665-2050, APLS IgM Pack, APLS IgM Reagent Pack
- Status
- Open, Classified
- Initiated
- 2023-02-28
- Posted
- 2023-05-10
- Terminated
- not on file
- Reason
- APLS IgM reagent kits were packaged with the incorrect conjugate, which could lead to an increase in false-positive and false-negative results.
- Root 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
- 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.
- Lot, serial or model codes
- Lot Code: 301538; UDI-DI: (00)847865000666
- 510(k) numbers
- ["K130528"]
- PMA numbers
- not on file
- Product code
- MID
- Firm FEI
- 3008272466
- Firm city
- Redmond
- Firm state
- WA
- Firm country
- not on file
Where this comes from
- Register
- FDA Medical Device Recalls (openFDA)
- Publisher
- U.S. Food and Drug Administration (openFDA)
- File
- device-recall-0001-of-0001.json.zip
- sha256
- b87518bfe2e8
- Size
- 288210821 bytes
- Published
- 2026-09-28
- Read
- 2026-09-29T08:25:23.626Z
- Source file
- Source file retained · verify
- Refresh due
- 2026-10-06
Unless otherwise noted, the content, data, documentation, code, and related materials on openFDA is public domain and made available with a Creative Commons CC0 1.0 Universal dedication.
Cite as
FDA Medical Device Recalls (openFDA) (U.S. Food and Drug Administration (openFDA)), device-recall-0001-of-0001.json.zip, sha256 b87518bfe2e8, published 2026-09-28