Health product recall

VYSIS CLL FISH PROBE KIT (2021-08-05)

Starting date:
August 5, 2021
Posting date:
August 27, 2021
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-76309

Last updated:
2021-08-27

Affected Products

VYSIS CLL FISH PROBE KIT

Reason

Abbott has received 9 reports of the Vysis Cll Fish Probe Kits not detecting 13q deletions in known positive patient samples. The D13S319 probe target contained within the probe mixture is intended to hybridize to chromosome location 13q14.3.

Affected products

VYSIS CLL FISH PROBE KIT

Lot or serial number

517086
518656

Model or catalog number

04N02-021

Companies
Manufacturer

Abbott Molecular Inc.

1300 E. Touhy Ave.

Des Plaines

60018

Illinois

UNITED STATES