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Anti-Human Globulin Anti-IgG (Rabbit) MTS Anti-IgG Card
- Starting date:
- January 31, 2017
- Posting date:
- February 28, 2017
- 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-62400
Reason
Ortho Clinical Diagnostics (Ortho) has initiated a recall due to the potential for false positive reactions when using specific lots of anti-human globulin Anti-IgG (rabbit) MTS Anti-IgG cards (MTS Anti-IgG cards).
It has been determined that affected MTS Anti-igg card lots may exhibit a varying low-level activity of anti-complement that may result in a false positive test.
Affected products
Anti-Human Globulin Anti-IgG (Rabbit) MTS Anti-IgG Card
Lot or serial number
- 101216001-50
- 101216001-51
- 101216001-53
- 101216001-55
- 101216001-56
- 101216001-57
- 101216001-58
- 101216001-60
Model or catalog number
MTS084024
Companies
- Manufacturer
-
Micro Typing Systems Inc.
1295 29th Ave. S.W.
Pompano Beach
33069
Florida
UNITED STATES