BioPlex 2200 REF 12000650 SYPH T PACK Syphilis Total & RPR Reagent Pack
Check against the official notice below — it lists the full affected range.
Bio-Rad Laboratories, Inc. is recalling the BioPlex 2200 REF 12000650 SYPH T PACK Syphilis Total & RPR Reagent Pack due to concerns that COVID-19 vaccines may interfere with the RPR (rapid plasma reagin) portion of the test panel, along with manufacturing challenges that have resulted in RPR reagents that do not consistently meet stability specifications. The recalled product, identified by catalog number 12000650 and lot number 301336, was distributed nationwide across 41 U.S. states and Puerto Rico, as well as internationally in France, Germany, Italy, Spain, Saudi Arabia, and the United Arab Emirates, with 9,426 packs recalled in the U.S.
The source document does not specify a remedy or recommended action for consumers who may have been affected by this recall.
Written by software from the official notice below. Not reviewed by a lawyer.
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
Reason for recall: 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 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. Quantity: 9,426 packs (U.S.) Lot/code info: Catalog Number: 12000650 UDI GTIN Code: 03610520653012 Lot Numbers: 301336
Official record: FDA (Device enforcement) ↗
Republished from the official source above; details can change — the source record controls.