Medical Device Recall (PR09-0082-0)
Cerner PathNet Blood Bank Donor
DATE NOTIFICATION INITIATED:
March 11, 2009
PRODUCT / LOT NUMBER:
Cerner HNA Classic PathNet Blood Bank Donor –Versions 306 and 015
MANUFACTURER:
Cerner Corporation
Kansas City, Missouri
REASON:
Cerner notified their customers that an issue has been identified where donor infectious disease testing interpretations and overall donor interpretation results may be performed using results from previous units with the same laboratory number. This issue occurs when a site re-uses a laboratory number set within two given years. Laboratory unit number is derived from the last six digits of the ISBT number. Interpretation can be completed before the actual testing has been resulted on the current units and/or, the old test results may be considered in the determination of the interpretation of the current unit. Therefore, the infectious disease testing and/or the overall donor interpretation for the current unit may be incorrect.
Customers are asked to start using unit numbers where the last six digits are unique. Also, to manually quarantine units as positive screening tests are identified; identify duplicate unit numbers, pay attention to their resulting process and use result entry functions (Result Entry-Accession and Result Entry –Profile) which use both the laboratory unit number and a unique number to identify a unit.
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.