Device recall

Z-0807-2022: BioPlex 2200 REF 12000651 Syphilis Total & RPR Calibrator Set CAL

FDA device recall · Class II · Bio-Rad Laboratories, Inc.

Key facts

Recall number (Z-number) Z-0807-2022
Recall event 89684
Product BioPlex 2200 REF 12000651 Syphilis Total & RPR Calibrator Set CAL
Product code LIP
Recalling firm Bio-Rad Laboratories, Inc.
Recall class Class II
Status Open, Classified
510(k) numbers K170413
FEI number 3008272466

At a glance

  • 1–9 Linked 510(k)s
  • 1–9 Products in the same recall event
  • 10–99 Recalled products with this product code

Counts are shown as ranges. Exact figures, trends and every underlying record are available in Orca1.

About FDA device recalls (products)

Each recalled device product receives a Z-number. Recall details such as root cause, distribution and firm actions are available in Orca1.

Source: U.S. Food and Drug Administration (FDA), Medical Device Recalls database

Browse all FDA device recalls (products)