Device recall

Z-0367-2020: RANDOX NEFA (Non-Esterified Fatty Acids) FA115 Lot 485343, GTIN: 5055273203066.

FDA device recall · Class III · Randox Laboratories, Limited

Key facts

Recall number (Z-number) Z-0367-2020
Recall event 84007
Product RANDOX NEFA (Non-Esterified Fatty Acids) FA115 Lot 485343, GTIN: 5055273203066.
Product code JLG
Recalling firm Randox Laboratories, Limited
Recall class Class III
Status Terminated
Termination date May 7, 2020
FEI number 1000361607

At a glance

  • None 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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