BioPlex 2200 REF 12000651 Syphilis Total & RPR Calibrator Set CAL
Check against the official notice below — it lists the full affected range.
Bio-Rad Laboratories, Inc. is recalling the BioPlex 2200 REF 12000651 Syphilis Total & RPR Calibrator Set due to concerns about COVID-19 vaccine interference with the RPR portion of the test panel, as well as intermittent manufacturing problems that prevented RPR reagents from consistently meeting stability specifications. The recalled product was distributed nationwide in the U.S., in Puerto Rico, and in France, Germany, Italy, Spain, Saudi Arabia, and the United Arab Emirates, with 724 calibrator sets recalled in the U.S.
The affected product has catalog number 12000651, UDI GTIN code 03610520652770, and lot number 53262. The source document does not specify what action affected consumers should take in response to 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: 724 Calibrator sets (U.S.) Lot/code info: Catalog Number: 12000651 UDI GTIN Code: 03610520652770 Lot Numbers: 53262
Official record: FDA (Device enforcement) ↗
Republished from the official source above; details can change — the source record controls.