Abbott Laboratories, Inc FDA Recalls

2 recalls on file across devices, 0 of them Class I and 2 still open. Matched by name to ABT.

Newest first

Class I is the FDA's most serious grade: a reasonable probability of serious harm or death.

Product	Reason	Class	Initiated
Alinity s System software version2.8.0, REF LN 06P16-01, IVD, OEI: (01)00380740138479 The Alinity s System is intendeClass IIFeb 3, 2022Software error associated with the immunoassay analyzer wash	Software error associated with the immunoassay analyzer wash cycle which is using 1 mL of wash buffer instead	Class IIDevices	Feb 3, 2022
Alinity s System REF 06P16-01. An automated immunoassay analyzer for In Vitro diagnostic use in blood donor screening,Class IIJul 12, 2021A design defect (hardware and software) allows liquid waste	A design defect (hardware and software) allows liquid waste pressure to build up and potentially spray users/o	Class IIDevices	Jul 12, 2021