BioPlex 2200 recallZ-1096-2022 · Bio-Rad Laboratories, Inc. · initiated Apr 14, 2022
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
Performance concerns for the CMV IgM analyte. Analyte has demonstrated variable elevated background depending on the handling of the reagent pack.
FDA root cause category: Under Investigation by firm
What the company is doing
On 04/14/2022, Bio-Rad Laboratories sent an "URGENT: Medical Device Recall" letter via FedEx to customers informing them that Bio-Rad has identified a performance concern for the CMV IgM analyte in the BioPlex 2200 ToRC IgM kit lot 301388. The CMV IgM analyte has demonstrated variable elevated background depending on the handling of the reagent pack. Agitation of the conjugate within the reagent pack has demonstrated a potential for both false negative and false positive results for the CMV IgM assay. QC failures may prevent the release of incorrect results; however, QC may not detect all occurrences of the issue. Customers are instructed to immediately discontinue use and to dispose of any unused product of Lot No. 301388. If the affected lot has been further distributed or transferred the product to other Bio-Rad customers, or labs, these customer/labs should be notified of this field action/recall. For questions or further assistance, contact local Bio-Rad Technical Support.
Recall details
- Recall number
- Z-1096-2022
- Status
- Open, Classified
- Initiated by the company
- Apr 14, 2022
- Recalling firm
- Bio-Rad Laboratories, Inc.
- Quantity
- 348 units
- Product code
- LIP
- Distribution
- Worldwide distribution - U.S. Nationwide distribution in the states of AR, AZ, CA, FL, HI, IA, IL, MI, MN, NE, NY, TN, TX, and WA. The countries of Czech Republic, France, Germany, and Italy.
Product description
BioPlex 2200 REF 12000670 ToRC IgM Reagent Pack
Code information (models, lots, serial numbers)
Model/Catalog Number: 12000670 UDI-DI (GTIN) Code: 03610520992715 Lot Number: 301388
Devices named in this recall
1 device in the FDA device registry whose identifier appears in the recall's code information.
- BioPlex 2200 12000670Bio-Rad Laboratories, Inc. · ENZYME LINKED IMMUNOABSORBENT ASSAY, TOXOPLASMA GONDII1 recall0 reports
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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