Recall Z-0806-2022— Bio-Rad Laboratories, Inc.

Name: FDA recall Z-0806-2022
Creator: U.S. Food and Drug Administration
Published: 2022-02-08

Class II · Ongoing

Class II FDA medical device recall by Bio-Rad Laboratories, Inc., initiated 2022-02-08. It names one FDA 510(k) clearance: K170413. Product: BioPlex 2200 REF 12000650 SYPH T PACK Syphilis Total & RPR Reagent Pack. Reason: 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.

Recalling firm: Bio-Rad Laboratories, Inc.
Classification: Class II
Status: Ongoing
Initiated: 2022-02-08
Firm location: Redmond, WA, United States

510(k) clearances named in this recall

1 on FDA's record

K170413 — BioPlex 2200 Syphilis Total & RPR, BioPlex 2200 Syphilis Total & RPR Calibrator Set, BioPlex 2200 Syphilis Total & RPR Control SetBio-Rad Laboratories·cleared 2017-05-11

K-numbers as listed on FDA's Recall Enterprise System record for this event (openFDA device/recall k_numbers). The recall may also cover devices cleared under other submissions not named here.

Product description

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

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

Data sourced from openFDA. This site is unofficial and independent of the FDA.