Skip to content

BioPlex 2200 recallZ-0806-2022 · Bio-Rad Laboratories, Inc. · initiated Feb 8, 2022

Open, Classified

Is my device affected?

  1. 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.
  2. 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.
  3. 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

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

FDA root cause category: Under Investigation by firm

What the company is doing

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 [email protected] 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 [email protected] or the Toll Free Fax 1-888-228-0688

Recall details

Recall number
Z-0806-2022
Status
Open, Classified
Initiated by the company
Feb 8, 2022
Recalling firm
Bio-Rad Laboratories, Inc.
Quantity
9,426 packs (U.S.)
Product code
LIP
FDA submissions
K170413
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.

Product description

BioPlex 2200 REF 12000650 SYPH T PACK Syphilis Total & RPR Reagent Pack

Code information (models, lots, serial numbers)

Catalog Number: 12000650 UDI GTIN Code: 03610520653012 Lot Numbers: 301336

Devices named in this recall

1 device in the FDA device registry whose identifier appears in the recall's code information.

Product lines

Other products in the same recall event

The FDA groups related products into one recall event (event 89684).

Sources and updates

How recalls are matched to devices · Editorial policy · Report an error on this page