BioFire Diagnostics FilmArray Pneumonia Panel (Pneumo), REF: RFIT-ASY-0145, For FILMARRAY recall — FDA Z-2440-2023
Due to manufacturing issue, panels may result in false negative results.
Browse the newest complete recall records currently stored from FDA enforcement reports and NHTSA vehicle campaigns. “Latest” refers to the newest source-dated record in this database, not the timestamp of our last API check.
The newest recall records with useful source details are listed here.
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.
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…
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.
There is a potential for a product packaging non-conformity issue which presents as a pinhole in either the inner or outer pouch.
Ground cable installed incorrectly.
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…
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…
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…
Product may be contaminated with Listeria monocytogenes.
Product may be contaminated with Listeria monocytogenes.
Product may be contaminated with Listeria monocytogenes.
The firm discovered that bottles labeled as Fanta Orange Zero Sugar actually contains regular Fanta Orange. The regular product contains 73g of sugar where the Fanta Zero contains 0g of…
Product may be contaminated with Listeria monocytogenes.
CGMP Deviations: Products not manufactured under current good manufacturing practices.
CGMP Deviations
CGMP Deviations
Subpotent: Out of Specification for Assay Test at the 3-month time point.
CGMP Deviations: Products not manufactured under current good manufacturing practices.
Labeling: Missing Label; customer complaint received that labels were partially or completely peeled off injection vial.
CGMP Deviations: Potential exposure to rodents and rodent activity in the distribution center. Also, due to unusually hot weather, FDA Recalled Products may have been subjected to…
Browse recent months with enough recall history for useful comparison.