Recall Z-2982-2020— Bio-Rad Laboratories, Inc.

Name: FDA recall Z-2982-2020
Creator: U.S. Food and Drug Administration
Published: 2020-04-21

Class II · Ongoing

Class II FDA medical device recall by Bio-Rad Laboratories, Inc., initiated 2020-04-21. It names one FDA 510(k) clearance: K170413. Product: 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 antibodies in human serum or plasma.. Reason: The increased level of RPR reactivity in the BioPlex 2200 Syphilis Total & RPR kit material number 12000650..

Recalling firm: Bio-Rad Laboratories, Inc.
Classification: Class II
Status: Ongoing
Initiated: 2020-04-21
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 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 antibodies in human serum or plasma.

Reason for recall

The increased level of RPR reactivity in the BioPlex 2200 Syphilis Total & RPR kit material number 12000650.

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