Device recall

Z-1830-2013: AIA Analyzer Pipette Tips used on Tosoh AIA-2000, AIA-1800, AIA-900 and…

FDA device recall · Class II · Tosoh Smd Inc

Key facts

Recall number (Z-number) Z-1830-2013
Recall event 65576
Product AIA Analyzer Pipette Tips used on Tosoh AIA-2000, AIA-1800, AIA-900 and AIA-600II Analyzers, 1000 tips/bag AIA-Analyzer Tips are disposable pipette tips packaged in bulk quantities and used on Tosoh Bioscience AIA Analyzers for lab analysis of various immunoassays.
Product code KHO
Recalling firm Tosoh Smd Inc
Recall class Class II
Status Terminated
Termination date Nov 27, 2013
510(k) numbers K971103
FEI number 3005529799

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

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