Health product recall

API 50CH

Brand(s)
Last updated

Summary

Product
API 50CH
Issue
Medical devices - Inaccurate test or measurement results
What to do
Contact the manufacturer if you require additional information.

Affected products

Affected Products Lot or serial number Model or catalog number
API 50CH 1008603700 Not applicable.

Issue

During the internal investigation of the non-conformance opened on API 50 CH sequence 40-49 lots #1008352920 and 1008510240 for false positive results on test 49 it was confirmed that test 19 of API 50 CH lot# 1008603700 contains a mix of sorbitol(SOR) and 5-Ketogluconic acid (5kg, which is contained in the solution of the test 49) instead of sorbitol only. The mix is estimated to represent almost 80% SOR and 20% 5kg.  During the investigation it was identified that test well 19 could be impacted on two API 50 CH lots, 1008603700 and 1008511380 and product stop shipment(PSS) was issued for both lots on 22 June 2021.   The NMR analysis was performed on well 19 of both API 50 CH lots, this testing confirmed that lot 1008511380 is conforming.

Recall date: 2021-08-13

Additional information

Details
Original published date:
Alert / recall type
Health product recall
Category
Health products - Medical devices - General hospital and personal use
Companies

BIOMERIEUX SA,

376, CHEMIN DE L'ORME, MARCY-L'ETOILE

France

 

 

Published by
Health Canada
Audience
General public
Health professionals
Hospitals
Recall class
Type II
Identification number
RA-63552