Medical equipment, implants, and diagnostic devices
The firm identified the potential for biased results to be generated when processing VITROS PHYT Slide product with citrate plasma specimen samples. The current Instructions for Use (IFU) and Assay Summary Chart state serum, heparin plasma, and citrate plasma as acceptable specimen types for use with the PHYT assay.
Uncontrolled couch Z-axis movement (descent)
Randox confirmed low calibration absorbance with HbA1c, Catalog Number HA3830, Batch 414553. The reagent may not continue to meet its specific performance characteristics throughout the shelf life of the product.
The serum may fail to agglutinate within the specified minimum reaction time.
Inadequate seal due to lack of adhesive glue
Stryker Neurovascular has become aware that some 3-Pack Stroke Fast Packs and Trevo Procedure Packs were manufactured using a carton sleeve where the sleeve label contents did not match the physical contents within the pack.
Qiagen, GmbH
Certain lots of the QIAamp DSP Virus Kit, REF 60704, used in analytic workflows could result in decreased performance.
Medacta has observed a worldwide occurrence rate of post-operative insert screw back-out of approximately 0.1%. For this reason, we stress the importance of using the 3.5 Nm torque limiting driver if the screw is used, as directed in our surgical techniques.
Philips Electronics North America
Some SureSigns VSi, VS2+ products have the Date of Manufacture on its serial number label as %DoM , instead of the specific date in the format of YYYY-MM.
Stryker Neurovascular
Stryker Neurovascular has become aware that some 3-Pack Stroke Fast Packs and Trevo Procedure Packs were manufactured using a carton sleeve where the sleeve label contents did not match the physical contents within the pack.
The device may contain a manufacturing condition affecting the geometry of the driver's hex feature which prevents it from properly engaging the fixture mount transfer and/or a dental implant.
The Spectra System/Legacy Guided Surgery Handle Kit had guided handle inserts that were out of Implant Direct specifications, from the results of complaints submitted by clinicians regarding the 3.4mm guide insert that will not allow the 3.4 drill to pass through, since the diameter is too small. In addition, the 2.3mm guide was too large.
QC failures (MIC out of range high) for S.aureus ATCC 29213 strain on ETEST OX 256 (OXACILLIN) Foam packaging (Ref. 520558, 520518) reported. The product behavior could lead to False Resistant results.
Hydrogel peeling from the pads.
Zimmer Dental
Some implant vial caps in the recalled implant lot may inadvertently crack as the result of a manufacturing assembly condition.
The device may contain a manufacturing condition affecting the geometry of the driver's hex feature which prevents it from properly engaging the fixture mount transfer and/or a dental implant.
Stryker Neurovascular has become aware that some 3-Pack Stroke Fast Packs and Trevo Procedure Packs were manufactured using a carton sleeve where the sleeve label contents did not match the physical contents within the pack.
Stryker Sustainability Solutions
3040 compression sleeves being mislabeled as a 3010-PL compression sleeves.
The device may contain a manufacturing condition affecting the geometry of the driver's hex feature which prevents it from properly engaging the fixture mount transfer and/or a dental implant.
Needle Bond may not be able to withstand the tension force applied when the shaped needle is deployed into and retracted from prostate tissue to deliver treatments.