H6: investigation summary bd received 6 photos and 100 tubes for investigation.The photos showed gel globules floating in the serum.In addition, 10 returned tubes from lot number 0009399 were therefore, drawn with horse blood, mixed, stood at room temperature for 30 minutes, before being centrifuged at 1862rcf for 10 minutes, using an mse mistral 1000 centrifuge.The supernatants were then decanted and examined under magnification for any signs of gel particles or globules.None were found.Based on a review of the device history record for the incident lot, all product specifications and requirements for lot release were met.There were no related quality issues during manufacturing of the product.A complaint history was performed, and this is the only complaint received on this lot number for the reported defect.The complaint is confirmed based on the photographs provided.No definitive root cause could be established for the reported defect; however it is understood that patient conditions, tube storage and processing conditions, and centrifugation settings, can impact on the quality of the serum and the presence of gel globules.Erroneous results was not evaluated further since the gel globules would be the cause of any erroneous results due to the blocked probe.
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