Medical device manufacturer, Ortho Clinical Diagnostics, has issued a medical device safety alert concerning its 0.8% Resolve Panel B [Product Codes (UDI): 6902318 (10758750007684); Lot: VRB282; Expiry: 20 Apr 2021].
The manufacturer received a customer complaint regarding a discrepancy between the Lewis B (Le(b)) antigen typing for VRB282 Cell 15 and results obtained during their Quality Control testing. The customer obtained a positive result and 0.8% Resolve Panel B Lot VRB282 Cell 15 was labeled as Le(b) negative on the ANTIGRAM Antigen Profile.
On review of the donor history, the manufacturer confirmed the donor as being Lewis B negative on initial qualification. However, the potential exists under specific circumstances for the Lewis antigen status of a donor to change as the Lewis Antigens are not intrinsic to the Red Blood Cell (RBC) membrane but are passively adsorbed. The manufacturer has deferred the donor from use in future manufacturing campaigns. Its investigation has confirmed that only Cell 15 is affected, all other cell results are correct.
The manufacturer has corrected the ANTIGRAM Antigen Profile for Reagent Red Blood Cells 0.8% Resolve Panel B Lot VRB282 to Le(b) positive for Cell 15. Affected users are instructed to use the corrected ANTIGRAM Antigen Profile to confirm the presence or absence of the Le(b) antigen. Other Le(b) negative cells are available in Ortho 0.8% Screening Cells as well as 0.8% Resolve Panels A and C.
According to the local supplier, the affected products are not distributed in Hong Kong.
If you are in possession of the products, please contact your supplier for necessary action.
Posted on 15 April 2021