FDA Medical Device Recalls (openFDA)
Bio-Rad Laboratories, Inc.: BioPlex 2200 REF 12000651 Syphilis Total & RPR Calibrator Set CAL
- Recall number
- Z-0807-2022
- Recalling firm
- Bio-Rad Laboratories, Inc.
- Product
- BioPlex 2200 REF 12000651 Syphilis Total & RPR Calibrator Set CAL
- Status
- Open, Classified
- Initiated
- 2022-02-08
- Posted
- not on file
- Terminated
- not on file
- Reason
- Due to current concerns related to COVID-19 vaccine interference with the RPR portion of the BioPlex 2200 Syphilis Total & RPR panel, as well as intermittent manufacturing challenges to produce RPR reagents that consistently meet stability specifications
- Root cause
- Under Investigation by firm
- Action
- On 02/08/2022, the firm sent out an "UGENT: Medical Device Correction" letter to customers via overnight FedEx informing them that the Recalling Firm continues to receive reports of false reactive RPR results despite labeling revisions and the previous Technical Bulleting dated December 2021 (LB003034revA). This is in response to ongoing concerns related to COVID-19 vaccine interference with RPR and the stability issue that led to the short dating of lot, the Recalling Firm is taking the additional field action to disable the RPR portion of the Syphilis Total and RPR panels until further notice. Customers are instructed to: 1. Dispose of the reagents according to local waste management procedures. 2. If they have further distributed or transferred the product to other customers, or labs from their site, notify those customer of this field action. 3. Complete Customer Response Form and email or fax the complete response form to local Bio-Rad Technical Support or email or fax the complete response form to your local Bio-Rad Technical Support. Please return this form to Techsupport.ussd@bio-rad.com or the Toll Free Fax 1-888-228-0688 within 10 days of receiving this notice. within 10 days of receiving this notice. The firm will be disabling (turn off the RPR analyte in the software) the RPR assay beginning with the reagent (Lot No. 301399 and calibrator (Lot No. 53440). If customers laboratory use of this reagent and calibrator, they will be unable to report RPR results. Customers are provided with directions for turning off the RPR analyte (see specific instructions attached to Customer Notification Letter). For questions or assistance, contact Bio-Rad Technical Support at email or fax the complete response form to your local Bio-Rad Technical Support. Please return this form to Techsupport.ussd@bio-rad.com or the Toll Free Fax 1-888-228-0688
- Quantity
- 724 Calibrator sets (U.S.)
- Distribution
- Worldwide distribution U.S. Nationwide distribution in the states of AK, AL, AZ, CA, CO, CT, FL, GA, HI, IA, IL, IN, KS, KY, LA, MA, ME, MI, MN, MO, MS, NC, ND, NE, NJ, NV, NY, OH, OK, OR, PA, Puerto Rico, RI, SC, SD, TN, TX, UT, VA, WA, WI, and WV. The countries of France, Germany, Italy, Spain, Saudi Arabia, and United Arab Emirates.
- Lot, serial or model codes
- Catalog Number: 12000651 UDI GTIN Code: 03610520652770 Lot Numbers: 53262
- 510(k) numbers
- ["K170413"]
- 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