Home / Recalls / Bio-Rad Laboratories, Inc. / Z-0235-2022

Z-0235-2022 Class II Ongoing

Recalled by Bio-Rad Laboratories, Inc. — Redmond, WA

FDA device recall Z-0235-2022 was initiated by Bio-Rad Laboratories, Inc. on September 17, 2021 and is designated Class II. Reason for recall: Due 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… The recall status is ongoing. Affected quantity: 11,610 units.

Recall Details

Product Type
Devices
Report Date
November 24, 2021
Initiation Date
September 17, 2021
Termination Date
N/A
Voluntary/Mandated
Voluntary: Firm initiated
Product Quantity
11,610 units

Product Description

BIO-RAD BioPlex 2200 REF 12000650 SYPH T PACK Syphilis Total & RPR Reagent Pack The BioPlex Syphilis Total & RPR kit is a multiplex flow immunoassay intended for the qualitative detection of total (IgG/IgM) antibodies to Treponema pallidum and the qualitative detection and/or titer determination of nontreponemal reagin antibodies in human serum or plasma

Reason for Recall

Due 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.

Distribution Pattern

Worldwide 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.

Code Information

Catalog Number: 12000650 UDI Code: 03610520653012 Lot Number: 301210

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  • Z-0806-2022 Class II — BioPlex 2200 REF 12000650 SYPH T PACK Syphilis Total & RPR Reagent Pack (February 8, 2022)
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FDA data resources