System DI-60 Main Unit and Remore Review Software (2017-07-27)

Starting date:

July 27, 2017

Posting date:

September 5, 2017

Type of communication:

Medical Device Recall

Subcategory:

Medical Device

Hazard classification:

Type III

Source of recall:

Health Canada

Issue:

Medical Devices

Audience:

General Public, Healthcare Professionals, Hospitals

Identification number:

RA-64384

• Reason
• Affected products

Affected Products

1. System Di-60 Main Unit
2. System Di-60 Remote Review Software

Reason

Sysmex America, Inc. has been made aware of a software defect on versions 5.0.1 and 6.0.1 running on the Sysmex DI-60 that may cause the operator to misidentify a slide flagged with a barcode error. If the Sysmex DI-60 processes a slide with an unreadable barcode, the barcode reader will take a picture of the barcode. The software will assign the slide a temporary id beginning with err in the format of erryyyymmddhhmmss (yyyy=year, mm=month, dd=day, hh=hour, mm=minute, ss=second). The image of the barcode will be stored in the database and displayed in the order data screen within the software so the customer can later identify the slide and reassign it with the correct sample id for the slide. If a subsequent slide is manually loaded on the Sysmex DI-60 and has a barcode with a err prefix, the slide will be linked with the image of the barcode from the prior slide the Sysmex DI-60 found unreadable. This can give the false impression the Sysmex DI-60 barcode reader could not read the barcode of the subsequent slide with a barcode with the err prefix. If the user is not careful there is a risk the user will assign the slide with the err prefix printed on it with an incorrect order id via the image captured from a different slide. The SP-10 will automatically auto-assign the sample id when unable to read the barcode on the tube in the format of err050000000001 and auto-increment. These slides are not automatically routed to the Sysmex DI-60.

Affected products