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MTS A/B/D Monoclonal and Reverse Grouping Card
- Starting date:
- November 5, 2012
- Posting date:
- December 10, 2012
- Type of communication:
- Medical Device Recall
- Subcategory:
- Medical Device
- Hazard classification:
- Type III
- Source of recall:
- Health Canada
- Issue:
- Medical Devices
- Audience:
- General Public (GP), Healthcare Professionals, Hospitals
- Identification number:
- RA-16279
Recalled Products
A. MTS A/B/D Monoclonal and Reverse Grouping Card
Reason
OCD has received complaints of an incomplete foil seal for specific lots of ID-Micro Typing System gel cards. Our investigation confirmed that some MTS gel cards exhibited a weaker or a loose foil seal resulting in the potential for drying of the first microtube. Using gel cards that exhibit drying in microtube(s) may cause false positive reactions leading to erroneous results.
Affected products
A. MTS A/B/D Monoclonal and Reverse Grouping Card
Lot or serial number
091312037-02
Model or catalog number
MTS080515
Companies
- Manufacturer
- Micro Typing Systems Inc.