Device recall

Z-1376-04: ProSpecT Cryptosporidium Microplate Assay. Catalog #2454096.

FDA device recall · Class III · Remel, Inc.

Key facts

Recall number (Z-number) Z-1376-04
Recall event 29681
Product ProSpecT Cryptosporidium Microplate Assay. Catalog #2454096.
Product code MHJ
Recalling firm Remel, Inc.
Recall class Class III
Status Terminated
Termination date Sep 15, 2004
510(k) numbers K031965
FEI number 1924669

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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