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HAEMOGLOBIN F AND A2 CONTROLS - LEVEL 1 AND 2 (Hb F & A2 CONTROL)

RANDOX LABORATORIES LIMITED · Model HA5083 · UDI-DI 05055273208832

GGM
10
510(k) clearances
2
Adverse events
2
Recalls
17
Facilities

Recalls

DateFirmReason
2018-10-18EUROTROL INCIncorrect measurement results caused by microbial contamination of the product, results in values lower than assigned values
2018-10-18EUROTROL INCIncorrect measurement results caused by microbial contamination of the product, results in values lower than assigned values

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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.