Device recall

Z-0145-2008: Accuprobe Group B Streptococcus Culture Identification Test, Catalog Number…

FDA device recall · Class II · Gen-Probe Inc

Key facts

Recall number (Z-number) Z-0145-2008
Recall event 44958
Product Accuprobe Group B Streptococcus Culture Identification Test, Catalog Number 2820B, Batch Number 531379, Gen-Probe, Incorporated, San Diego, CA. 92121
Product code MDK
Recalling firm Gen-Probe Inc
Recall class Class II
Status Terminated
Termination date May 3, 2010
510(k) numbers K974572
FEI number 2024800

At a glance

  • 1–9 Linked 510(k)s
  • 1–9 Products in the same recall event
  • 1–9 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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