VARIANT NBS Newborn Screening System - Sickle Cell Program (2020-02-27)
- Starting date:
- February 27, 2020
- Posting date:
- March 13, 2020
- 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-72587
Last updated: 2020-03-13
Affected Products
VARIANT NBS Newborn Screening System - Sickle Cell Program
Reason
Bio-Rad has found that the printed english VARIANT NBS Sickle Cell Program instructions for use (IFU) included in the lots mentioned above of the VARIANT NBS Sickle Cell Program reorder pack is the incorrect version. It does not match the correct IFU version that is on the included multiple-language CD (MLCD) Kindly note that the differences between the IFU versions do not affect the product performance.
Affected products
VARIANT NBS Newborn Screening System - Sickle Cell Program
Lot or serial number
64320366
Model or catalog number
250-3000
Companies
- Manufacturer
-
Bio-Rad Laboratories, Inc.
4000 Alfred Nobel Dr.
Hercules
94547
California
UNITED STATES