All Recalls

Subpotent Drug; sub-potent Bromfenac levels, below the 90.0-110.0% specification range.

As part of the firm's ongoing quality monitoring (see internal complaint # OCC72574), Randox Laboratories have restandardized Ferritin in Liquid Protein Calibrators, IT2691, to reference material NISBC 19/118. The calibrators lots 2112IT-2116IT, packed into batches 627222, 627224, 634886 and 634887 have been reassigned as part of the restandardization. Following this restandardization, Ferritin results for Quality Control material and patient samples recovered erroneously higher than the targeted calibrator values by approximately +10% across the assay range following.

The air/water valve MAJ-1444 used with OER-Pro and OER-Elite may become damaged and result in loss of the one-way valve functionality by repeated automated endoscope reprocessing in Olympus OER machines, causing body fluid could backflow into the air/water channel of the ultrasonic endoscopes during the procedure.

There is a potential for ADVIA Chemistry Urinary/Cerebrospinal Fluid Protein reagent carryover impacting Enzymatic Creatinine_2 (ECRE_2). Falsely depressed ECRE_2 results may be observed when the assay is processed after the UCFP test on ADVIA Chemistry systems.

There is a potential for a rare interaction between the EMBLEM S-ICD and LATITUDE communicator, which may cause S-ICD sensing disablement for a 24-hour interval.

Ground cable installed incorrectly.

There is a potential for a product packaging non-conformity issue which presents as a pinhole in either the inner or outer pouch.

There is a potential for a product packaging non-conformity issue which presents as a pinhole in either the inner or outer pouch.

Due to manufacturing issue, panels may result in false negative results.

There is a potential for a product packaging non-conformity issue which presents as a pinhole in either the inner or outer pouch.

Presence of polyether polyurethane (PE-PUR) and emission of 1,3-Dichloropropan-2-ol that exceed the acceptable uptake level during continuous use (>30 days) in pediatric patients.

There is a potential for a product packaging non-conformity issue which presents as a pinhole in either the inner or outer pouch.

There is a potential for a product packaging non-conformity issue which presents as a pinhole in either the inner or outer pouch.

A complaint was received indicating that a package contained a TRIGEN TROCHANTERIC ANTEGRADE NAIL LIME 11.5MM X 40CM 130 DEGREE LEFT implant instead of a TRIGEN TROCHANTERIC ANTEGRADE NAIL LIME 11.5MM X 36CM 130 DEGREE LEFT as described on the product label.

There is a potential for a product packaging non-conformity issue which presents as a pinhole in either the inner or outer pouch.

Due to manufacturing issue, panels may result in false negative results.

There is a potential for a rare interaction between the EMBLEM S-ICD and LATITUDE communicator, which may cause S-ICD sensing disablement for a 24-hour interval.

There is a potential for a product packaging non-conformity issue which presents as a pinhole in either the inner or outer pouch.

(1) There is vial to vial variation resulting in some vials recovering positive for hCG, which should be negative and (2) high and outside range for cortisol. (3) There has been a transcription error for Creatinine in the Instructions For Use (IFU). The target and ranges for Creatinine for the Roche Creatinine Plus method have been listed incorrectly. These failures cause a delay in patient results for the above mentioned analytes.

There is a potential for a product packaging non-conformity issue which presents as a pinhole in either the inner or outer pouch.