Pneumococci Factor 7F Antisera (2018-11-19)
- Starting date:
- November 19, 2018
- Posting date:
- January 8, 2019
- 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-68672
Affected products
Pneumococci Factor 7F Antisera
Reason
Pneumococcus factor 7f antisera from SSI Diagnostica, cat# 16931 (SS), Lot # C7F17U1 (expiry 05/14/2021) and Lot # C7F17X1 (expiry 03/11/2022) is subject to a recall. It has been determined that these 2 lots show a weak reaction for positive samples, and it is difficult to distinguish between positive and negative reactions.
Affected products
Pneumococci Factor 7F Antisera
Lot or serial number
- C7F17U1
- C7F17X1
Model or catalog number
- 16931
Companies
- Manufacturer
-
SSI DIAGNOSTICA A/S
2 HERREDSVEJEN
HILLROD
3400
DENMARK