Device Recall H. pylori (polyclonal) 의 리콜

Recall

77209

Class 2

Z-2202-2017

2017-05-05

2017-06-01

Terminated

United States

2017-09-07

USFDA

https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfres/res.cfm?id=155441

Cell marque has determined the need to issue a product recall after identifying product intended to be sold outside the u.S. was not properly labeled as "for export only" as required by section 801 (e )(1) of the fd&c; act.

Cell Marque sent notification letters by e-mail directly to domestic customers who were shipping affected products on May 9, 2017. Letters asked that unused product be destroyed and that amount destroyed and amount already used be recorded on the acknowledgment form and returned per instructions. UPDATE: Firm called DO on May 24, 2017 to inform us that the recall letters did not go out as expected on May 9, 2917 due to employee not performing assigned task. Director of Quality made sure letters went out on May 24th by e-mail and has already received some responses. She will also follow op with personal phone calls. Customers with questions were instructed to contact their Customer Care team at 800-665-7284 or 916-746-8900 or email sevrice@cellmarque.com. For questions regarding this recall call 916-746-8977.