The customer observed multiple falsely reactive chagas blood donor specimens while using prism chagas reagents.The specimen results were repeat reactive using the prism reagents, however did not confirm.The following data was provided (s/co): chagas tests: sid (b)(6) initial 3.47 (reactive), repeat 3.69, 3.86 (reactive), sid (b)(6) initial 4.64 (reactive), repeat 5.16, 4.48 (reactive), sid (b)(6) initial 2.64 (reactive), repeat 2.49, 2.93 (reactive), sid (b)(6) initial 4.92 (reactive), repeat 4.37, 5.16 (reactive).No specific values were provided for sid (b)(6).All the units were t.Cruzi (chagas) negative using a supplemental method, with the exception of sid (b)(6) that returned an intermediate result.There was no impact to patient management reported.
|
Further investigation of the customer issue included a review of the complaint text, a search for similar complaints, review of instrument logs, a review of labeling and specificity testing.No adverse trend was identified for the customer's issue.Labeling was reviewed and found to be adequate.Clinical specificity testing of negative control replicates was performed using in-house retained kits stored at the recommended storage condition.Specificity testing met all specifications.Based on all available information and abbott diagnostics' complaint investigation no product deficiency was identified.
|