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DATE PRODUCT CORRECTION INITIATED:
PRODUCT:
Ortho Assay Protocol Diskette (OAPD) for the Vironostika HTLV-I/II Microelisa system; Revision 1
MANUFACTURER:
Ortho Clinical Diagnostics, Inc.
Raritan, New Jersey
REASON:
Ortho Clinical Diagnostics has received reports of inconsistent liquid levels after pipetting Human T-Lymphotropic Viruses Type I and Type II (HTLV-I/II) microwell plates on the Summit. Ortho's investigation has confirmed that a residual amount of the HTLV-I/II sample diluent adheres to the exterior portion of the Summit disposable pipette tip after delivery to the microwell plate. Consignees are asked to install the updated OAPD and follow the installation instructions for the Ortho Summit Processor found in the HTLV-I/II OAPD Package Insert.
The information in this listing reflects CBER's best efforts to communicate information that has been reported to FDA. Its accuracy and comprehensiveness cannot be guaranteed.
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