Device recall

Z-0302-2014: VITROS Chemistry Products Ca Slides packaged as 300 slides/pack catalog number…

FDA device recall · Class II · Ortho-Clinical Diagnostics

Key facts

Recall number (Z-number) Z-0302-2014
Recall event 65572
Product VITROS Chemistry Products Ca Slides packaged as 300 slides/pack catalog number 1450261 VITROS Ca Slides quantitatively measure calcium (Ca) concentration in serum, plasma, and urine using VITROS 250/350/950/5,1 FS and 4600 Chemistry Systems and the VITROS 5600 Integrated System.
Product code CJY
Recalling firm Ortho-Clinical Diagnostics
Recall class Class II
Status Terminated
Termination date Apr 11, 2017
510(k) numbers K072440
FEI number 1000136573

At a glance

  • 1–9 Linked 510(k)s
  • 10–99 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)