The Food and Drug Administration (FDA) recently posted the following safety alerts:
Stryker Scandinavian Total Ankle Replacement (STAR) Device
The FDA has posted a safety communication regarding a higher than expected risk of the polyethylene component of the STAR device breaking as early as 3 to 4 years after implantation. Fracture of the plastic component of the STAR Ankle may require surgery to repair or replace the device. The potential risk of the polyethylene component breaking may exist for all STAR Ankle devices, regardless of the date of manufacture or distribution. The FDA believes the STAR Ankle remains appropriate for certain patient populations, such as older patients with lower activity levels. Based on the additional medical literature and real-world evidence, patients with more active life styles, osteoarthritis, or age younger than 55 years old may have a higher than expected risk of the plastic component breaking. The FDA is providing recommendations to help patients and health care providers monitor for signs of possible fracture of the plastic component in the STAR Ankle. More Information.
Roche Cobas SARS-CoV2 and Influenza Tests
The FDA is alerting clinical laboratory staff, point-of-care facility staff, and health care providers that false positive results can occur with the Roche Molecular Systems Inc. cobas SARS-CoV-2 & Influenza A/B Nucleic Acid Test for use on the cobas Liat System. The assay tubes may sporadically leak, causing an obstructed optical path in the Liat analyzer, producing abnormal PCR growth curves. This could lead to invalid or erroneous positive results, particularly for the Flu B test. If a tube leak occurs, later testing runs may have an increased likelihood of false positive Flu B results. The abnormal PCR cycling in the reaction tubes may also produce abnormal PCR growth curves, leading to erroneous results. More Information.
Sagent Pharmaceuticals Phenylephrine
Sagent Pharmaceuticals announced the voluntary nationwide recall of 3 lots of phenylephrine hydrochloride injection (10 mg/mL). This product was manufactured by Indoco Remedies Ltd. and distributed by Sagent Pharmaceuticals Inc. Sagent has initiated this voluntary recall as the result of a customer complaint due to potentially loose crimped vial overseals. A non-integral crimped vial overseal may result in a non-sterile product. Intravenous administration of a product intended to be sterile that is not sterile could result in serious systemic infections which may be life-threatening. The possibility of a breach in sterility assurance in distributed product, while remote, cannot be eliminated. To date, Sagent has not received reports of any adverse events associated with this issue. More Information.