Device recall

Z-0544-2022: KWIK-STIK, Enterobacter cloacae subsp. cloacae derived from ATCC 13047, REF…

FDA device recall · Class III · Microbiologics Inc

Key facts

Recall number (Z-number) Z-0544-2022
Recall event 89380
Product KWIK-STIK, Enterobacter cloacae subsp. cloacae derived from ATCC 13047, REF 0323P. Packaged 2 units per pack. IVD controls.
Product code JTR
Recalling firm Microbiologics Inc
Recall class Class III
Status Terminated
Termination date Jul 11, 2022
510(k) numbers K861022
FEI number 2150138

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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