Abbott Laboratories v.1.2 Upgrade Kit or v.1.2 upgrade installed on WorkMate Claris" System recall — FDA Z-1854-2021
Due to a software error, the user may lose functionality of the system or the screen may turn black during operation.
Complete FDA and NHTSA recall records dated in 2021, organized for browsing by month, category and recalling company.
Select a month to review the recall records reported during that period.
Records are ordered by the best available source date.
Due to a software error, the user may lose functionality of the system or the screen may turn black during operation.
Specific lots may have been manufactured with insufficient or incomplete welds.
The company was notified by their supplier of sterilization services for airway products in Italy of potential deviations from validated parameters for ethylene oxide sterilization.
Specific lots may have been manufactured with insufficient or incomplete welds.
Specific lots may have been manufactured with insufficient or incomplete welds.
The product may have a yellowish-brown/greenish-brown residue present at the tip of the cannula.
Specific lots may have been manufactured with insufficient or incomplete welds.
Specific lots may have been manufactured with insufficient or incomplete welds.
Due to an issue with the internal clock of the analyzers with an e3800 PC unit installed.
The device is used as part of extracorporeal membrane oxygenation (ECMO) cardiopulmonary bypass circuits and may collapse during use which can increase resistance to flow in the venous line…
Due to insufficient column strength of the racks for all load conditions, racks associated with height adjustment functionality have been observed deforming, which may lead to increased…
Reports of the proximal end of the stent not immediately expanding upon deployment and remaining connected to the delivery system.
The IGS system can experience a single vertical line defect where the vertical line divides and horizontally shifts live monitor images into two unequal image parts within the monitor…
Specific lots may have been manufactured with insufficient or incomplete welds.
Specific lots may have been manufactured with insufficient or incomplete welds.
Specific lots may have been manufactured with insufficient or incomplete welds.
Specific lots may have been manufactured with insufficient or incomplete welds.
Specific lots may have been manufactured with insufficient or incomplete welds.
Specific lots may have been manufactured with insufficient or incomplete welds.
Specific lots may have been manufactured with insufficient or incomplete welds.
The lot may have experienced an anomaly during the manufacturing process, that could lead to an out of specification concentrate formulation.
Due to an issue with the internal clock of the analyzers with an e3800 PC unit installed.
Specific lots may have been manufactured with insufficient or incomplete welds.
Specific lots may have been manufactured with insufficient or incomplete welds.
This archive groups records by their reported or recall date. It does not imply that every recall was initiated, announced and resolved during the same calendar year. Open the individual record for the exact dates and source details supplied by FDA or NHTSA.