Device recall

Z-2223-2009: BioTek Gen5CL Microplate Data Collection and Analysis Software. Intended for…

FDA device recall · Class II · BioTek Instruments, Inc.

Key facts

Recall number (Z-number) Z-2223-2009
Recall event 52218
Product BioTek Gen5CL Microplate Data Collection and Analysis Software. Intended for clinical lab use with ELx800 and ELx808 microplate readers, offers preprogrammed clinical diagnostic assays within a PC-based application.
Product code JJQ
Recalling firm BioTek Instruments, Inc.
Recall class Class II
Status Terminated
Termination date May 18, 2015
FEI number 1217454

At a glance

  • None 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

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