FDA News Briefs for Friday, May 24, 2019May 24, 2019
These Food and Drug Administration (FDA) developments came in this week:
Safety Update: Endoscope Port Connectors
The FDA has issued a letter announcing the FDA clearance of a modified Erbe USA Inc. Erbeflo port connector designed to help reduce the risk of cross-contamination that was identified in the FDA’s April 18, 2018 Letter to Health Care Providers and Staff at Health Care Facilities. The design of the modified port connector added a backflow prevention feature as recommended in FDA guidance. More Information.
Recall Notice: Beckman Coulter Hematology Analyzers
Beckman Coulter is recalling the DxH 800, DxH 600, and DxH 900 Hematology Analyzers due to sporadic erroneously elevated platelet count results without flags or system messages, meaning there is no way for the laboratory operator of the test to recognize the error. Inaccurate platelet counts may cause serious adverse health consequences. More Information.
FDA Authorizes Diagnostic Test for Zika Virus
The FDA has authorized marketing of a diagnostic test to detect Zika virus immunoglobulin (IgM) antibodies in human blood. The ZIKV Detect 2.0 IgM Capture ELISA is the first Zika diagnostic test the FDA has allowed to be marketed in the U.S.; previously, tests for detecting Zika virus IgM antibodies—including the ZIKV Detect 2.0 IgM Capture ELISA—had been authorized only for emergency use under the FDA’s Emergency Use Authorization (EUA) authority. More Information.
FDA Clears Tests for Extragenital Testing for Chlamydia and Gonorrhea
The FDA has cleared 2 tests for marketing that can detect the presence of the bacteria Chlamydia trachomatis and Neisseria gonorrhoeae through diagnostic testing of extragenital specimens. The Aptima Combo 2 Assay and the Xpert CT/NG are the first devices cleared for extragenital diagnostic testing for these infections via the throat and rectum. More Information.