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Recall Observatory FDA recall evidence

Device evidence

device-recall:cfres:112213

IDS-iSYS Intact PINP Control Set, Catalog Number IS-4030. Packaged in cardboard Box containing plastic bottles. The IDS-iSYS Intact amino-terminal propeptide of type I procollagen (Intact PINP) Control Set is used for quality control of the IDS-iSYS Intact PINP Assay on the IDS-iSYS Multi-Discipline Automated Analyser.

Official recall number

Z-0045-2013

Evidence summary

Product code
JIT
Recall status
Terminated
Event initiated
August 10, 2012
Root cause
Labeling False and Misleading
Source snapshot
5482458777762b1480c71ac49b2913b9c7984bb55aac66a4315d018da7cfed2c
Product
Z-0045-2013