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