This page has been archived on the Web
Information identified as archived is provided for reference, research or recordkeeping purposes. It is not subject to the Government of Canada Web Standards and has not been altered or updated since it was archived. Please contact us to request a format other than those available.
KI67-MM1 Concentrate and KI67-MM1 Bond Ready To Use (RTU) (2015-04-13)
- Starting date:
- April 13, 2015
- Posting date:
- May 21, 2015
- 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-53391
Recalled Products
- KI67-MM1 Concentrate
- KI67-MM1 Bond Ready To Use (RTU)
Reason
Leica Biosystems Newcastle Ltd recently became aware that the various formats of the affected products do not consistently perform as expected and in some instances have exhibited weaker than expected staining.
Affected products
A. KI67-MM1 Concentrate
Lot or serial number
- 6027899
- 6031742
- 6033082
Model or catalog number
NCL-L-KI67-MM1
Companies
- Manufacturer
-
Leica Biosystems Newcastle Ltd.
Balliol Business Park West
Benton Lane
UNITED KINGDOM
B. KI67-MM1 Bond Ready To Use (RTU)
Lot or serial number
- 28251
- 29784
- 29879
- 29880
- 30673
- 30683
Model or catalog number
PA0118
Companies
- Manufacturer
-
Leica Biosystems Newcastle Ltd.
Balliol Business Park West
Benton Lane
UNITED KINGDOM