Device recall

Z-1259-2011: Bio-Rad Variant II Turbo Link Hemoglobin Testing System, including Hemoglobin A…

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

Key facts

Recall number (Z-number) Z-1259-2011
Recall event 54746
Product Bio-Rad Variant II Turbo Link Hemoglobin Testing System, including Hemoglobin A, Program Reorder Pack 1600 Tests, Program Buffer A, Buffer B, Cartridge Set, Analytical Cartridge, Guard Cartridge, Calibrator, Accessory Box, Instruction Manual and Quick Guide Intended use: Measurement of Hemoglobin…
Product code LCP
Recalling firm Bio-Rad Laboratories Inc
Recall class Class II
Status Terminated
Termination date Mar 3, 2011
510(k) numbers K070819
FEI number 2915274

At a glance

  • 1–9 Linked 510(k)s
  • 1–9 Products in the same recall event
  • 100–999 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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