Device recall

Z-0787-06: Aspergillus Niger Microbial Suspension, Model Numbers: 16404-100 (100 dose) and…

FDA device recall · Class III · Biological and Environmental Control Laboratories Inc

Key facts

Recall number (Z-number) Z-0787-06
Recall event 35178
Product Aspergillus Niger Microbial Suspension, Model Numbers: 16404-100 (100 dose) and 16404-20 (20 dose). The product labeling reads as follows: ''b.e.c. Growth-Chek Microbial Suspensions/Aspergillus niger Derived from ATCC Culture #16404**** Store Under Refrigeration***10mL *Shake Well''. The product is…
Product code JTR
Recalling firm Biological and Environmental Control Laboratories Inc
Recall class Class III
Status Terminated
Termination date Mar 1, 2012
FEI number 1525897

At a glance

  • None 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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