Home / Recalls / Bio-Rad Laboratories, Inc. / Z-1377-2023

Z-1377-2023 Class II Ongoing

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

Recall Details

Product Type
Devices
Report Date
April 19, 2023
Initiation Date
February 21, 2023
Termination Date
N/A
Voluntary/Mandated
Voluntary: Firm initiated
Product Quantity
1544 units

Product Description

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

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.

Distribution Pattern

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

Code Information

Lot # 301481; UDI GTIN: 00847865000857

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