Device recall

Z-1363-2019: Technopath Multichem S Plus Level 2 - Product Usage: Multichem S Plus (Assayed)…

FDA device recall · Class III · Abbott Laboratories

Key facts

Recall number (Z-number) Z-1363-2019
Recall event 82590
Product Technopath Multichem S Plus Level 2 - Product Usage: Multichem S Plus (Assayed) is intended for use as an assayed quality control serum to monitor the precision of laboratory testing procedures for the analytes listed in the package insert.
Product code JJY
Recalling firm Abbott Laboratories
Recall class Class III
Status Terminated
Termination date Dec 20, 2019
510(k) numbers K132751
FEI number 1415939

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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