BioPlex 2200 Syphilis Total & RPR Linked Immunoabsorption Assay, Treponema pallidum:UDI:03610520653012 - Product Usage: intended for the qualitative detection of total (IgG/IgM) antibodies to Treponema pallidum and the qualitative detection and/or titer determination of non-treponemal reagin antibod
Check against the official notice below — it lists the full affected range.
Bio-Rad Laboratories recalled 12,000 kits of its BioPlex 2200 Syphilis Total & RPR assay (material number 12000650) due to increased levels of RPR reactivity in the test material. The affected kits were distributed worldwide, including throughout the United States and in Canada, Switzerland, France, Italy, Spain, Romania, and the United Kingdom. The recall involves reagent lot 301142 and later manufactured lots, as well as calibrator lot 52216.
The BioPlex 2200 Syphilis Total & RPR assay is intended to qualitatively detect syphilis antibodies. Beginning with the affected lot numbers, Bio-Rad will disable the RPR portion of the assay. The source document does not specify what actions affected consumers or facilities should take in response to this recall.
Written by software from the official notice below. Not reviewed by a lawyer.
The increased level of RPR reactivity in the BioPlex 2200 Syphilis Total & RPR kit material number 12000650.
Reason for recall: The increased level of RPR reactivity in the BioPlex 2200 Syphilis Total & RPR kit material number 12000650. Distribution: Worldwide distribution - US Nationwide distribution including in the states of AK, AL, AZ, CA, CO, CT, FL,GA, HI, IA, IL, IN, KS, KY, LA, MA, MD, ME, MI, MN, MO, MS, NC, ND, NE, NJ, NV, NY, OH, OK, OR, PA, PR, RI, SC, SD, TX, UT, VA, WA, WI, and WV. The countries of Canada (CA), Switzerland (CH), France (FR), Italy (IT), Spain (ES), and Romania (RO), and United Kingdom (GB). Quantity: 12000 kits Lot/code info: The RPR assay will be disabled beginning with reagent lot 301142 and future manufactured lots of the BioPlex 2200 Syphilis Total & RPR assay (Catalog No. 12000650, UDI 03610520653012) and calibrator lot 52216 (Catalog No. 12000651, UDI 03610520652770). Product Code 1: ENZYME LINKED IMMUNOABSORPTION ASSAY, TREPONEMA PALLIDUM (LIP), Product Code 2: ANTIGENS, NONTREPONEMAL, ALL (GMQ), Product Code 3: CALIBRATOR, SECONDARY (JIT), Product Code 4:SINGLE (SPECIFIED) ANALYTE CONTROLS (ASSAYED AND UNASSAYED) (JJX).
Official record: FDA (Device enforcement) ↗
Republished from the official source above; details can change — the source record controls.