All Recalls

Lack of Assurance of Sterility: Inadequate processes and equipment to assure the sterility of products intended to be sterile.

Superpotent Drug.

Defective Container: vial defect was identified that could potentially impact the container closure and result in a lack of sterility assurance and/or the potential for glass particles.

Labeling: Not eslewhere classified - The kits include Sodium Chloride, USP, 0.9% which was recalled by the manufacturer due to the product insert incorrectly stating stoppers do not contain latex. The stoppers contain natural rubber latex

Subpotent Drug: Isotretinoin content results were lower than the specification limit obtained during routing product monitoring.

Lack of Sterility Assurance and Incorrect/Undeclared excipient: Product was found to contain undeclared colloidal silver

Presence of foreign tablet/capsule: A single foreign tablet was found in pharmacy dispensed bottle of 30 Estradiol 2 mg tablets.

Superpotent Drug: recalled lots may have higher concentration of ibuprofen.

Labeling: Wrong bar code

Failed Dissolution Specifications.

Sub-potent

Failed Impurities/Degradation Specifications:Out of specification for impurities.

Subpotent Drug:Out of specification for percentage of active pharmaceutical ingredients.

Shortfill: Aprepitant capsules 40 mg is being recalled due to customer reports of missing capsule in the blister pack.

Superpotent Drug: contains higher levels of Iron than labeled.

lack of 510K

The VITEK¿ 2 Systems Software Version 9.01 software may display incorrect organism identification information as well as the associated Antimicrobial Susceptibility Testing (AST) results when using the VITEK¿ 2 FLEXPREP" feature.

The lens bonding was incomplete on the refractor.

Siemens Healthcare Diagnostics has identified an issue with Dimension Vista software v.3.7 and v.3.8.1 that may result in aliquot well contamination. If a test is cancelled by the operator while the instrument is aliquotting the sample, the Dimension Vista instrument may continue to deliver the cancelled sample or vial contents to the aliquot well(s). Future samples may be assigned to the same aliquot well(s) and become contaminated with the existing contents or overflow of the aliquot well may occur potentially contaminating a surrounding well(s). This issue only occurs when an operator manually cancels a test(s) for calibration, quality control (QC) or patient sample while the instrument is in the process of aliquotting the sample.

Issue #1 affects Software Versions 6.0 SP7, SP7.0.1, SP7.0.2, SP7.0.3, SP8, SP8.0.1, SP8.0.a and SP8.0.2. When an image is flipped horizontally and vertically, the orientation markers appear correctly on the image to which they were applied. However, once new image rendering happens on this image or series (with scrolling; playing cin¿; maximizing or changing viewports/layouts; or synchronizing viewports and resizing the browser), the new image orientation is correctly maintained but the display of orientation markers can become incorrect. Issue #2 affects Software Versions 6.0 SP7, SP7.0.1, SP7.0.2, SP7.0.3, SP8, SP8.0.1, SP8.0.a, SP8.0.2, SP9 and SP9.0.1. When an image in a series is flipped and then rotated in Zero Footprint Viewer (ZFP), the orientation markers appear correctly on the image to which they were applied. However, once you navigate to another image in the series and the image you navigated to has a different orientation than the prior image from which you navigated, the new image orientation is correctly maintained but the display of orientation markers can become incorrect.