FDA Medical Device Recalls (openFDA)
Bio-Rad Laboratories, Inc.: BioPlex 2200 REF 12000670 ToRC IgM Reagent Pack
- Recall number
- Z-1096-2022
- Recalling firm
- Bio-Rad Laboratories, Inc.
- Product
- BioPlex 2200 REF 12000670 ToRC IgM Reagent Pack
- Status
- Open, Classified
- Initiated
- 2022-04-14
- Posted
- not on file
- Terminated
- not on file
- Reason
- Performance concerns for the CMV IgM analyte. Analyte has demonstrated variable elevated background depending on the handling of the reagent pack.
- Root cause
- Under Investigation by firm
- Action
- 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.
- Quantity
- 348 units
- 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.
- Lot, serial or model codes
- Model/Catalog Number: 12000670 UDI-DI (GTIN) Code: 03610520992715 Lot Number: 301388
- 510(k) numbers
- not on file
- PMA numbers
- not on file
- Product code
- LIP
- 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