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Recall Observatory FDA recall evidence

Device evidence

device-recall:cfres:167211

Software Package, iPAW 4.2 User Kit, Part No. B73489, Manufactured by: Beckman Coulter Biomedical GmbH The iPAW 4.2 User Kit (PN B73489) includes the iPAW software application CD (version 4.2). This function is primarily used to copy an existing barcode ID to replace the label of an individual sample tube because the original label is deteriorated.

Official recall number

Z-0356-2019

Evidence summary

Product code
JQP
Recall status
Terminated
Event initiated
May 24, 2018
Root cause
Software change control
Source snapshot
d51b4b87fdeb9ccf809d8b814d67f3a0fa43ac67bead6c171fe27284699c3275
Product
Z-0356-2019

Field note

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