Pointe Scientific Liquid Glucose (HEXO) Reagent Set 의 리콜

Recall

53583

Class 1

Z-0104-2010

2009-10-19

2009-11-04

Terminated

United States

2010-09-27

USFDA

https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfres/res.cfm?id=85912

There is a loss of linearity. the product fails to maintain linearity specification of 500 mg/dl.

The firm issued a press release, and an amended press release, on 10/30/09. Consignees were notified by an Urgent: Medical Device Recall letter dated 10/19/09, which identified the problem; and, instructed testing laboratories to inform patients' attending physicians, and determine, with their input, whether confirmation of the previous test results will be required. Customers are to examine their inventory for any of the lot numbers listed on the letter; and, for any product that has been further distributed, those customers need to be identified and notified of this product recall by including a copy of the recall letter. Customers are to complete and return the Recall Return Response form and upon receipt, Pointe Scientific will replace any disposed of reagent. The recall was expanded to include two additional lots by letter dated 11/2/09.