Massachusetts recalls

Software defect, which allows the system to accept erroneous, non-monotonous calibrations for Spline-type assays. Cobas pro integrated solutions is an automated analyzer, intended for running qualitative, semi-quantitative and quantitative clinical chemistry and immunochemistry assays, as well as ion-selective measurements. When an erroneous calibration is active, the instrument fails to calculate new values and instead repeats the last successfully calculated result from any Spline-type assay for all subsequent measurements, leading to identical and erroneous patient and QC results. The defect could lead to patients receiving erroneous lab results, which could result in a remote risk of serious adverse health consequences. The following assays use spline type calibration and are affected by this issue: Cystatin C Gen.2, Ferritin Gen.4, Lipoprotein (a) Gen. 2, Lipoprotein (a) molarity, Vancomycin Gen.3, Kappa Free Light Chains Partner Channel, Lambda Free Light Chains Partner Channel, and fCAL turbo Partner Channel.

Under certain workflows, patient information shown in the viewer may not match the images displayed on Centricity Universal Viewer Zero Footprint Client (ZFP) with versions ZFP v6.0: SP11.6, SP11.6.0.1 and SP11.6.1 on systems with Patient Timeline installed,

Differential pressure (dP) sensor in Impella RP devices may malfunction, causing sensor values to drift.

Differential pressure (dP) sensor in Impella RP devices may malfunction, causing sensor values to drift.

Differential pressure (dP) sensor in Impella RP devices may malfunction, causing sensor values to drift.

Failed Dissolution Specifications

Marketed Without an Approved NDA/ANDA: FDA analysis revealed the presence of undeclared sildenafil and tadalafil

Marketed Without an Approved NDA/ANDA-FDA analysis revealed undeclared sildenafil (13.1 mg/capsule) and tadalafil (13.8 mg/capsule).

Presence of Particulate Matter: Due to production issues

Marketed Without an Approved NDA/ANDA: FDA analysis revealed the presence of undeclared meloxicam.

Stability Data Does Not Support Expiry Date.

Stability Data Does Not Support Expiry Date.

Stability Data Does Not Support Expiry Date.

Failed Impurities/Degradation Specifications: An out-of-specification result observed during 9th-month long term stability testing

Defective container; inadequately sealed blister packaging.

Failed Tablet/Capsule Specifications: Observed OOS results at 6-months long-term stability condition for Description test and Appearance by Visual Inspection test.

Failed Tablet/Capsule Specifications: Observed OOS results at 6-months long-term stability condition for Description test and Appearance by Visual Inspection test.

CGMP Deviations This recall has been initiated due to failing to complete process validation and bacterial endotoxin method validation before distribution

CGMP Deviations This recall has been initiated due to failing to complete process validation and bacterial endotoxin method validation before distribution

CGMP Deviations

CGMP Deviations

CGMP Deviations

CGMP Deviations

CGMP Deviations

CGMP Deviations

CGMP Deviations

CGMP Deviations

CGMP Deviations

CGMP Deviations

CGMP Deviations