Device recall

Z-0536-2007: Microalbumin Multi-Calibrator Set, in vitro diagnostic. Catalog Number: SE-252

FDA device recall · Class III · Diagnostic Chemicals, Ltd.

Key facts

Recall number (Z-number) Z-0536-2007
Recall event 36864
Product Microalbumin Multi-Calibrator Set, in vitro diagnostic. Catalog Number: SE-252
Product code JIX
Recalling firm Diagnostic Chemicals, Ltd.
Recall class Class III
Status Terminated
Termination date May 14, 2007
510(k) numbers K042243
FEI number 3002806809

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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