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Blood Grouping Reagent MTS A/B/D Monoclonal and Reverse Grouping Card (2014-07-07)
- Starting date:
- July 7, 2014
- Posting date:
- July 25, 2014
- Type of communication:
- Medical Device Recall
- Subcategory:
- Medical Device
- Hazard classification:
- Type II
- Source of recall:
- Health Canada
- Issue:
- Medical Devices
- Audience:
- General Public, Healthcare Professionals, Hospitals
- Identification number:
- RA-40629
Recalled Products
Blood Grouping Reagent MTS A/B/D Monoclonal and Reverse Grouping Card
Reason
Ortho Clinical Diagnostics (OCD) observed an increased number of complaints related to false positive and/or reactions containing haze in the Anti-A and buffered gel microtubes used for reverse ABO typing in the MTS A/B/D Monoclonal and Reverse Grouping Card lots listed above. Our investigation determined that the false positive reactions were due to broken gel beads in the microtubes of the MTS cards.
Affected products
Blood Grouping Reagent MTS A/B/D Monoclonal and Reverse Grouping Card
Lot or serial number
02413037-53
120213037-55
Model or catalog number
MTS080515
Companies
- Manufacturer
-
Micro Typing Systems Inc.
1295 29th Ave. S.W.
Pompano Beach
33069
Florida
UNITED STATES