Abbott i-STAT EG7+ cartridge-IVD recall — FDA Z-0881-2021
Ionized calcium test on some i-STAT CG8+ and EG7+ cartridges may exhibit higher than expected reported results when stored at room temperature (18 to 30C) for periods of time in excess of 3…
Browse the newest complete recall records currently stored from FDA enforcement reports and NHTSA vehicle campaigns. “Latest” refers to the newest source-dated record in this database, not the timestamp of our last API check.
The newest recall records with useful source details are listed here.
Ionized calcium test on some i-STAT CG8+ and EG7+ cartridges may exhibit higher than expected reported results when stored at room temperature (18 to 30C) for periods of time in excess of 3…
The electrical contactor component present in the drying chamber of the Reliance Vision Single-Chamber Washer/Disinfector may malfunction, potentially leading to the heating elements in the…
A small number of Neurosign 100 Intraoperative Nerve Monitors may have been dispatched without being configured appropriately for the supply mains within the target Country. The specific…
When a user creates a measurement tool annotation in the uPath Enterprise software version 1.1, the measurement value is incorrectly calculated when the measurement is viewed in "Split…
A discrepancy was found between the Mixing Instruction Card and the Instructions for Use for the 5cc and 10 cc bone void filler kits. No customer complaints or reports of injury have been…
Neonatal Valves were manufactured with a ventricular catheter connection site shorter than the design specification. The defect can lead to difficulty in securing the valve to the proximal…
The catheter may become susceptible to distal tip damage during use. Distal tip damage in conjunction with pressurization of contrast injection may result in potential vessel damage, and…
The instruments may become cold welded together when the drill is inserted through the Soft Tissue Guide. This prevents disassociation of the instruments and potentially leads to an…
The catheter may become susceptible to distal tip damage during use. Distal tip damage in conjunction with pressurization of contrast injection may result in potential vessel damage, and…
Neonatal Valves were manufactured with a ventricular catheter connection site shorter than the design specification. The defect can lead to difficulty in securing the valve to the proximal…
Component failures may cause the unit to lose all suction. Users will need to obtain alternate suction devices or methods, leading to a delay in treatment and, in worst case scenario,…
Ionized calcium test on some i-STAT CG8+ and EG7+ cartridges may exhibit higher than expected reported results when stored at room temperature (18 to 30C) for periods of time in excess of 3…
There is potential for fractures which results in the inability to delivery therapy.
Possible metal shavings.
Contain Eggs was not listed on scale label printed at retail stores. Label does state that the product May contain any of the eight allergen that are listed out on the label,
Product is potentially contaminated with mold.
Contain Eggs was not listed on scale label printed at retail stores. Label does state that the product May contain any of the eight allergen that are listed out on the label,
Contain Eggs was not listed on scale label printed at retail stores. Label does state that the product May contain any of the eight allergen that are listed out on the label,
Contain Eggs was not listed on scale label printed at retail stores. Label does state that the product May contain any of the eight allergen that are listed out on the label,
Contain Eggs was not listed on scale label printed at retail stores. Label does state that the product May contain any of the eight allergen that are listed out on the label,
Contain Eggs was not listed on scale label printed at retail stores. Label does state that the product May contain any of the eight allergen that are listed out on the label,
Undeclared wheat.
CGMP deviations: Lack of potency testing.
CGMP deviations: Lack of potency testing.
Browse recent months with enough recall history for useful comparison.