Recall Z-1572-2023— Bio-Rad Laboratories, Inc.

Name: FDA recall Z-1572-2023
Creator: U.S. Food and Drug Administration
Published: 2023-02-28

Class II · Ongoing

Class II FDA medical device recall by Bio-Rad Laboratories, Inc., initiated 2023-02-28. It names one FDA 510(k) clearance: K130528. Product: BioPlex 2200 REF 665-2050, APLS IgM Pack, APLS IgM Reagent Pack. Reason: APLS IgM reagent kits were packaged with the incorrect conjugate, which could lead to an increase in false-positive and false-negative results..

Recalling firm: Bio-Rad Laboratories, Inc.
Classification: Class II
Status: Ongoing
Initiated: 2023-02-28
Firm location: Redmond, WA, United States

510(k) clearances named in this recall

1 on FDA's record

K130528 — BIOPLEX 2200 APLS IGMBio-Rad Laboratories·cleared 2013-10-21

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 665-2050, APLS IgM Pack, APLS IgM Reagent Pack

Reason for recall

APLS IgM reagent kits were packaged with the incorrect conjugate, which could lead to an increase in false-positive and false-negative results.

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