Unknown manufacturer: there are multiple bd locations where this unspecified bd device may have been manufactured.A catalog and lot number could not be confirmed for this incident and without this information we are unable to determine where the device was manufactured.Therefore, bd corporate headquarters in (b)(4) has been listed in and the (b)(4) fda registration number has been used for the manufacture report number.Date of event: unknown.The date received by manufacturer has been used for this field.Medical device expiration date: unknown.Device manufacture date: unknown.Investigation summary: bd had not received samples or photos for evaluation.Additionally, bd was unable to determine the specific material and lot number associated with this complaint; therefore, a review of the device history record could not be conducted.Material number 8516333 was provided, which is not valid.It was determined that he authors did not follow the manufacturer¿s assay instructions for ipth which state that, ¿specimens may be stored on or off the clot, or red blood cells for up to 2 days refrigerated at 2-8°c.If testing will be delayed more than 2 days, remove serum or plasma from the clot, or red blood cells and store frozen.¿ therefore, the study test results do not present a valid measure of product performance and do not point to a product performance issue.This complaint is unable to be confirmed.If additional information is made available, this complaint will be reopened to assess the level of investigation needed.
|