FDA Device Intelligence
HomeDevice types › MZA

Test, Equipment, Automated Bloodborne Pathogen

FDA product code MZA · Class N · Unknown

44
Registered devices
190
Adverse events
3
Recalls
0
510(k) clearances

Devices with this code

Recent recalls

DateFirmReason
2022-02-03Abbott Laboratories, IncSoftware error associated with the immunoassay analyzer wash cycle which is using 1 mL of wash buffer instead of the intended 3 mL of wash buffer to wash the e
2021-07-12Abbott Laboratories, IncA design defect (hardware and software) allows liquid waste pressure to build up and potentially spray users/operators.
2013-05-06Ortho-Clinical DiagnosticsThere is evidence that an electrical short within the systems connector has caused an accumulation of heat which has radiated back through the wiring harness c

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Sourced from public U.S. FDA data. Informational only — not medical or regulatory advice. Not affiliated with the FDA.