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Non-Esterified Fatty Acids (NEFA)

RANDOX LABORATORIES LIMITED · Model FA115 · UDI-DI 05055273203066

JLG
2
510(k) clearances
0
Adverse events
1
Recalls
1
Facilities

Recalls

DateFirmReason
2019-09-23Randox Laboratories, LimitedNon-Esterified Fatty Acids (NEFA) FA115 batch 485343 is not meeting the performance claims and should not be used in any further testing.

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Data compiled from public U.S. FDA sources (GUDID, 510(k)/PMA, MAUDE, recalls, establishment registration). Adverse-event reports are unverified and do not establish causation. Informational only — not medical, clinical, or regulatory advice.