Last night, Canadian Blood Services issued a recall to hospitals relating to 1,500 units of blood for which one of our standard tests – for the cytomegalovirus (CMV) – was not performed according to specifications for a period of three days. The recalled blood components were tested at our Calgary donor testing laboratory between July 30 and Aug. 2, 2013. The error was discovered this week during a routine records audit. The recall is for mislabeled products. Even though it appears to have been a minor error, and the risk to patients is very low, we did not follow procedures. So, we cannot have full confidence in the test results, nor can we stand behind the labeling claim that the units are CMV negative. There are very strict requirements in biologics manufacturing and in our regulations for recalling products that are mislabeled. While 1,500 is the total number of units covered in the recall, that does not mean we are actually removing that amount from inventory. Of the total, approximately 250 units are still in our possession. These units are being relabeled correctly and returned to inventory. We estimate there are about 400 units remaining on hospital shelves. We have asked hospitals to return those units to us so that we can use them for product quality studies. The remaining components have either been transfused or have outdated. Both our internal and external medical opinion is that the testing error is of very low risk (see background below) and may not warrant patient notification except under specific conditions that would be decided by the treating clinicians. Despite the risk being low, and being able to repurpose some of these units, this recall is very disruptive to Canadian Blood Services and to the hospitals we serve. This incident once again highlights how critical it is for us to diligently follow approved standard operating procedures. We’ll continue to monitor our inventory and work with hospitals to ensure the recall does not have a negative impact on patient care. We’ll also look to learn from this incident and make necessary changes to ensure it doesn’t happen again.
Posted on: Sun, 25 Aug 2013 00:08:43 +0000
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