BioPlex 2200 recallZ-1572-2023 · Bio-Rad Laboratories, Inc. · initiated Feb 28, 2023
Open, Classified
Is my device affected?
- Compare the model, catalog and lot or serial numbers on your device or its packaging with the code information below. A recall usually covers only specific models or lots.
- If yours is listed, follow the instructions from Bio-Rad Laboratories, Inc. or your healthcare provider. The company's action is summarized under what the company is doing.
- Do not stop using a prescribed or implanted device on your own — talk to your healthcare provider first.
Where to find your model and lot numbers · What recall classes and statuses mean
Why it was recalled
APLS IgM reagent kits were packaged with the incorrect conjugate, which could lead to an increase in false-positive and false-negative results.
FDA root cause category: Under Investigation by firm
What the company is doing
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.
Recall details
- Recall number
- Z-1572-2023
- Status
- Open, Classified
- Initiated by the company
- Feb 28, 2023
- Posted by the FDA
- May 10, 2023
- Recalling firm
- Bio-Rad Laboratories, Inc.
- Quantity
- 932 Reagent Packs
- Product code
- MID
- FDA submissions
- K130528
- 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.
Product description
BioPlex 2200 REF 665-2050, APLS IgM Pack, APLS IgM Reagent Pack
Code information (models, lots, serial numbers)
Lot Code: 301538; UDI-DI: (00)847865000666
Devices named in this recall
1 device in the FDA device registry whose identifier appears in the recall's code information.
- BioPlex 2200 6652050Bio-Rad Laboratories, Inc. · System,test,antibodies,b2 - glycoprotein i (b2 - gpi)1 recall1 report
Product lines
Sources and updates
- Recall record: FDA Medical Device Recalls, file dated Oct 16, 2026 · View the FDA recall notice ↗
- Devices: FDA GUDID, file dated Oct 13, 2026. Devices are linked when their identifier (with a valid check digit) appears in the recall's code information.
- Page last rebuilt: Oct 16, 2026. Text above is shown as published by the FDA.
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