Health product recall

Poch-Pack L

Last updated

Summary

Product
Poch-Pack L
Issue
Medical devices - Software defect
What to do

Contact the manufacturer if you require additional information.

Affected products

Affected products

Lot or serial number

Model or catalog number

Poch-Pack L

P1003
P1004
P1005

PPL-200A

Issue

The encrypted barcode data generates an error that prevents the analyzer from using the entire contents of the bottle. The user is required to replace the reagent container prematurely. On 4/25/22, the issue was identified through the trending of post market surveillance data and the complaint handling process. Inventory of the affected lot numbers were placed on hold on 4/26/22.

Recall start date: April 25, 2022

Additional information

Details
Original published date: 2022-06-03
Alert / recall type
Health product recall
Category
Health product - Medical device - Haematology
Companies

Sysmex Corporation

1-5-1 Wakinohama-Kaigandori, Kobe, Hyogo-Ken, Japan, 651-0073

Published by
Health Canada
Audience
General public
Health professionals
Hospitals
Recall class
Type II
Identification number
RA-64210