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Bio-Rad Laboratories, Inc. Recall 88874

Description: BIO-RAD BioPlex 2200 REF 12000651 Syphilis Total & RPR Calibrator Set CAL The BioPlex 2200 Syphilis Total & RPR Calibrator Set is intended for the calibration of the BioPlex 2200 Syphilis Total & RPR Reagent Pack.

Bio-Rad Laboratories, Inc. Recall 88874 Information

StatusOngoing
Mandated?Voluntary: Firm initiated
Recall NumberZ-0236-2022
Event ID88874
Event DescriptionBIO-RAD BioPlex 2200 REF 12000651 Syphilis Total & RPR Calibrator Set CAL The BioPlex 2200 Syphilis Total & RPR Calibrator Set is intended for the calibration of the BioPlex 2200 Syphilis Total & RPR Reagent Pack.
Product TypeDevices
DistributionWorldwide Distribution: U.S.(nationwide) including 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, SC, SD, TN, TX, UT, VA, WA, WI, and WV; O.U.S.(foreign) countries of: France, Germany, Israel, Italy, Russian Federation, South Africa, Spain, and Taiwan.
Quantity791 units
Recall ReasonDue to two issues: 1) Customer complaints associated with greater than expected Rapid Plasma Reagin (RPR) reactivity which does not confirm with treponemal antibody test which may be due to a positive correlation between the mass COVID vaccinations and false reactive RPR results, and 2) During routine stability monitoring, an increase in mean bias above specification was observed which can cause elevated RPR reactivity potentially due to early shelf-life failure.
Device Classification20211124
Device Code InfoCatalog Number: 12000651 UDI Code: 03610520652770 Lot Number: 52953
Center Classification Date20211116
Recall Initiation Date20210917
Recalling FirmBio-Rad Laboratories, Inc.
Initial Notification Letter
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