Health product recall

IH-1000 (2018-03-13)

Starting date:
March 13, 2018
Posting date:
April 6, 2018
Type of communication:
Medical Device Recall
Subcategory:
Medical Device
Hazard classification:
Type II
Source of recall:
Health Canada
Issue:
Medical Devices
Audience:
General Public, Healthcare Professionals, Hospitals
Identification number:
RA-66380

Affected products

IH-1000

Reason

When a reagent vial with an unreadable barcode is loaded on a reagents rack on IH-1000 (software version 04.07.02) and a test is performed, despite the fact the first reagent is correctly pipetted, the instrument will pipette in the vial with unreadable barcode for all the remaining wells.

Affected products

IH-1000

Lot or serial number

Not applicable

Model or catalog number

001000

Companies
Manufacturer

Diamed GMBH

Pra Rond 23

Cressier FR

1785

SWITZERLAND