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

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  Reason
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  Affected products

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