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All product recalls associated with Sybaritic, Inc.
Total Recalls
1000
Past Year
304
Class I (Serious)
34
Most Recent
Nov 2025
Data from FDA, USDA, CPSC, and NHTSA public records. Recall counts vary by company size, industry, and reporting practices. Always check official sources for current information.
Misbranded and sale without pre-market notification.
Some of the labels are glossy, resulting in the bar code being difficult to read by the bar code reader.
Some of the labels are glossy, resulting in the bar code being difficult to read by the bar code reader.
Some of the labels are glossy, resulting in the bar code being difficult to read by the bar code reader.
Some of the labels are glossy, resulting in the bar code being difficult to read by the bar code reader.
Some of the labels are glossy, resulting in the bar code being difficult to read by the bar code reader.
Some of the labels are glossy, resulting in the bar code being difficult to read by the bar code reader.
Some of the labels are glossy, resulting in the bar code being difficult to read by the bar code reader.
AxSYM TDM/ Transplant Assay Disks 3D53-03 and higher do not contain the AxSYM Digoxin II Assay file. The instrument might require installation of the AxSYM Digoxin II assay file.
The field action was initiated after the firm confirmed that the Coat-A-Count PSA IRMA kit (IKPS1, 2, 5, X) exhibits a low bias, which is evident when comparing results with other methods, including the IMMULITE PSA kits. Coat-A-Count PSA IRMA results are, for example, approximately 20% lower when compared to results obtained with the IMMULITE 2000 Third Generation PSA assay (L2KUP).
The firm received and confirmed that some lots of Cardiac Troponin I (cTnl) CalPaks (CCTNI-CR) may exhibit calibration issues that cause lower than typical signal during calibration with the current population of cTnl TestPaks (CCTNI). This issue may result in failed calibrations due to "Slope Error" messages or falsely elevated patient sample and quality control (QC) results on calibrations that
Beverage may contain glass particles.
falsely elevated results in EDTA plasma samples
Sybaritic Inc. had an issue with the 585nm filter used with the NannoLight MP50. The filter may cause unwanted burning and should not be used for vascular lesion treatments.
possibility of falsely elevated results
False negative hCG results due to decreased sensitivity
AMO initiated this field correction event after becoming aware of a trend in complaints associated with AMO Vitrectomy Cutter used in conjunction with the AMO WHITESTAR SIGNATURE Phacoemulsification System. The physician may be unable to make a cut during cataract surgery.
False Results: The product may exhibit falsely elevated results. The affected lots demonstrate sporadic variability in recovery of calibrator and quality control; therefore this issue may not be readily detected upon calibration or during routine processing of Quality Control.
Possible mismatch between patient and result.
Precipitate in product may cause elevated background absorbance interference.