This page has been archived on the Web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.
VITROS Immunodiagnostic Products Total T4 Reagent Pack (2016-06-03)
- Starting date:
- June 3, 2016
- Posting date:
- June 24, 2016
- Type of communication:
- Medical Device Recall
- Subcategory:
- Medical Device
- Hazard classification:
- Type III
- Source of recall:
- Health Canada
- Issue:
- Medical Devices
- Audience:
- Hospitals, Healthcare Professionals, General Public
- Identification number:
- RA-59028
Affected products
A. VITROS Immunodiagnostic Products Total T4 Reagent Pack
Reason
Ortho Clinical Diagnostics (Ortho) has initiated this recall because it was determined that the open pack (in use) storage limits must be reduced from 8 weeks to 4 weeks for VITROS Immunodiagnostic products total T4 (TT4) reagent packs. This change affects expired, current (in date) and future product lots.
Affected products
A. VITROS Immunodiagnostic Products Total T4 Reagent Pack
Lot or serial number
- 1836
- 1845
- 1860
- 1880
- 1890
- 1900
- 1930
- 1950
- 1968
Model or catalog number
- 8744468
Companies
- Manufacturer
-
ORTHO-CLINICAL DIAGNOSTICS
FELINDRE MEADOWS, PENCOED, BRIDGEND