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Particulate matter in the microparticle component.
A 4 Fr catheter was packaged in PICC convenience kits labeled as 3 Fr.
Increased level of non-specific or background staining.
Patient images may be incorrectly stored in the archive directory of a different patient.
A software upgrade was released by the firm for its AIA-600 II analyzers, in that washing deficiencies caused by the analyzer were corrected.
The quality control samples for Vancomycin would not recover correctly when compared to the S.I. unit values listed in the incorrectly printed product insert. The incorrectly printed values were higher than they should be by a factor of 3 (three).
CryoLife initiated a retrospective review per FDA request, to insure that current regulatory guidelines for donor blood testing have been met for certain donors.
Products contain software deficiencies which could allow over infusion thereby administering excess medication.
Software anomally, One client reported patient tests and results are deleted when duplicate orders are placed.
Patients may become entrapped between the bottom side rail and mattress.
software problem - loss of data
Urgent care STAT reports are not printing in a timely fashion.
Complaints that the stents are being dislodged from the delivery system.
Two reports of leakage.
The product has a software condition in that the surface temperature of the transducer may reach above the thermal limit.
Lot gives lower specimen results compared to results generated with other lots.
Software problem may cause the instrument to skip the probe-wash step before processing different reagents.