AutoDELFIA System with Version 3.0 Software: Potential plate loading failures
All Recalls
95,089 total recalls in our database
Customer complaints identified that samples containing extremely high IgG4 levels exhibit antigen excess and will yield spuriously low IgG4 results.
Outer Packaging is not sterile
Allura Xper FD20/15 R8.2 722058 is intended for: Cardiovascular and vascular X-ray imaging applications, including diagnostic, interventional procedures (such as PTCA, stent placement and atherectomies), pacemaker implantations and Electro Physiology(EP).
Philips Electronics North America
Due to a production error, screws were not tightened to specified torque. These screws may come loose from the C-arm shaft causing the C-arm to rotate uncontrolled.
Brilliance iCT
Philips Medical Systems (Cleveland)
During a retrospective review of production documentation it was observed that the M6 Rotor Counterweight Bolt may have been improperly torqued.
Optilite IgG4 Kit Product Code: LK009.OPT.A
The Binding Site Group
A change to the lower end of the measuring range and product insert did not reflect the change.The measuring range provided in instrument parameters is correct but contradicts the information provided in the product insert
Baxter Healthcare Corporation is issuing a voluntary product recall for several lots of Phoenix Dialysis Machine Preventive Maintenance Kits due to incorrect silicone straight connectors components packaged in these kits. During Preventive Maintenance, the two silicone connectors must be installed in the Phoenix mass-balance section of hydraulic circuit only if the Phoenix machine has already been modified with "CONN. IMPROVING RETR. KIT" (Code SP00721). Installation of these connectors in machines modified with SP00721 may result in fluid leaks during dialysis treatment. These Preventive Maintenance Kits include the FILTER sub-group, which contains the silicone straight connectors that are larger than expected.
Velara Generator with an old Firmware version used with Philips Allura Xper Systems (Allura 15 & 12 (monoplane), Allura FD10C, Allura FD10F, Allura FD 10 F/C, Allura FD20, Allura XPER FD10/10, Allura XPER FD20 Biplane)
Philips Electronics North America
System may lock up.
Customer complaints identified that samples containing extremely high IgG4 levels exhibit antigen excess and will yield spuriously low IgG4 results.
Outer Packaging is not sterile
Sekisui Diagnostics Ammonia L3K¿ Assay; Catalog Number: 293-80-91 and 293-10 For the IN VITRO quantitative measurement of ammonia concentration in plasma
Sekisui Diagnostics P.E.I.
Certain lots are showing an atypical decrease in optical density (OD) over time, which may result in an impact to performance at the high end of the linear range.
AutoDELFIA System with Version 3.0 Software: Potential plate loading failures
Product resistance has fallen outside of label claim within expiry.
Pentax is initiating a Field Correction to revise the Instructions for Use of the Rigid Laryngostroboscopes Model 9106 and 9108.
Outer Packaging is not sterile
Allura Xper FD20 722012 is intended for: Cardiovascular and vascular X-ray imaging applications, including diagnostic, interventional procedures (such as PTCA, stent placement and atherectomies), pacemaker implantations and Electro Physiology(EP).
Philips Electronics North America
Due to a production error, screws were not tightened to specified torque. These screws may come loose from the C-arm shaft causing the C-arm to rotate uncontrolled.
AutoDELFIA System with Version 3.0 Software: Potential plate loading failures
NOOK® Tablet 7"
Unknown Manufacturer
The power adapter casing can break when plugged into an electrical outlet, exposing its metal prongs, posing an electric shock hazard.
Bar chairs
3i Corporation, of Hong Kong
The legs can become detached from the center post at the weld, posing a fall hazard.
Two Over Two 4-drawer dressers
Unknown Manufacturer
The recalled dressers are unstable if they are not anchored to the wall, posing a serious tip-over and entrapment hazard that can result in death or injuries to children. The dressers do not comply with the performance requirements of the U.S. voluntary industry standard (ASTM F2057-14).