Bio-Rad Laboratories, Inc.: Medical Device Recall in 2023 - (Recall #: Z-1377-2023)

Updated on March 25, 2026.

See the recall detail below. You can also see other recalls from the same firm in 2023.

Data Source: FDA.

Product Description:

BioPlex 2200, Anti-CCP Reagent Pack, REF 665-3250, IVD

Product Classification:

Class II

Date Initiated: February 21, 2023

Date Posted: April 19, 2023

Recall Number: Z-1377-2023

Event ID: 91854

Reason for Recall:

Bio-Rad received four customer complaints from 11/30/2022 to 12/21/2022 on BioPlex 2200 Anti-CCP Kit (Lot 301481) stating that results were discrepant while performing lot-to-lot validation against previous lots. Internal testing at Bio-Rad has demonstrated that Lot No. 301481 exhibits a specificity of 94.5% (95% CI 91.8 96.4) whereas the IFU indicates a specificity of 97.8% (95% CI 96.1 98.8%). The reduction in specificity may lead to an increase in the number of false positives.

Status: Ongoing

Product Quantity: 1544 units

Code Information:

Lot # 301481; UDI GTIN: 00847865000857

Distribution Pattern:

Worldwide distribution - US Nationwide and the countries of Canada, Czech Republic, Germany, Spain, France, United Kingdom, Israel, Italy, Norway, Sweden.

Voluntary or Mandated:

Voluntary: Firm initiated