Various ID-MTS Gel Cards products (2018-04-25)
- Starting date:
- April 25, 2018
- Posting date:
- May 4, 2018
- 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-66704
Affected products
A. MTS Buffered Gel Card
B. MTS Anti-IgG Card
C. MTS A/B/D Monoclonal Grouping Card
D. MTS A/B/D/Monoclonal and Reverse Grouping Card
E. MTS IgG,-C3d Card
F. MTS Monoclonal Control Card
G. MTS Anti-A,B Card
H. MTS Anti-E Card
I. MTS Anti-C Card
Reason
Ortho Clinical Diagnostics (Ortho) has initiated this recall as it may potentially affect the ID-MTS Gel Cards. The gel card trays are stored in paper board trays. The gel card trays may contain an increased amount of white dust/debris from the trays that can adhere to the outer surface of the cards. Ortho has confirmed reports of white dust/debris on the outer surface of various ID-MTS Gel Cards products. While the issue does not affect use of the ID-MTS Gel Cards in manual method, Ortho has identified that the adhering of white dust/debris on the outer surface of the cards may potentially affect the performance of the cards on ORTHO VISION and ORTHO VISION Max Analyzer.
Affected products
A. MTS Buffered Gel Card
Lot or serial number
011518004-01
092917004-01
101217004-01
120417004-01
Model or catalog number
MTS085014
Companies
- Manufacturer
-
Micro Typing Systems Inc.
1295 29th Ave. S.W.
Pompano Beach
33069
UNITED STATES
B. MTS Anti-IgG Card
Lot or serial number
More than 10 numbers, contact manufacturer.
Model or catalog number
MTS084024
Companies
- Manufacturer
-
Micro Typing Systems Inc.
1295 29th Ave. S.W.
Pompano Beach
33069
UNITED STATES
C. MTS A/B/D Monoclonal Grouping Card
Lot or serial number
010818053-01
010818053-02
010818053-03
010818053-04
081117053-02
081117053-03
081117053-04
101317053-02
101317053-03
101317053-04
Model or catalog number
MTS081115
Companies
- Manufacturer
-
Micro Typing Systems Inc.
1295 29th Ave. S.W.
Pompano Beach
33069
UNITED STATES
D. MTS A/B/D/Monoclonal and Reverse Grouping Card
Lot or serial number
More than 10 numbers, contact manufacturer.
Model or catalog number
MTS080515
Companies
- Manufacturer
-
Micro Typing Systems Inc.
1295 29th Ave. S.W.
Pompano Beach
33069
UNITED STATES
E. MTS IgG,-C3d Card
Lot or serial number
062617005-01
100417005-01
111317005-01
Model or catalog number
MTS084014
Companies
- Manufacturer
-
Micro Typing Systems Inc.
1295 29th Ave. S.W.
Pompano Beach
33069
UNITED STATES
F. MTS Monoclonal Control Card
Lot or serial number
102417042-01
Model or catalog number
MTS081001
Companies
- Manufacturer
-
Micro Typing Systems Inc.
1295 29th Ave. S.W.
Pompano Beach
33069
UNITED STATES
G. MTS Anti-A,B Card
Lot or serial number
083017038-01
121317038-01
Model or catalog number
MTS080016
Companies
- Manufacturer
-
Micro Typing Systems Inc.
1295 29th Ave. S.W.
Pompano Beach
33069
UNITED STATES
H. MTS Anti-E Card
Lot or serial number
102617047-01
Model or catalog number
MTS080212
Companies
- Manufacturer
-
Micro Typing Systems Inc.
1295 29th Ave. S.W.
Pompano Beach
33069
UNITED STATES
I. MTS Anti-C Card
Lot or serial number
110217045-01
Model or catalog number
MTS080210
Companies
- Manufacturer
-
Micro Typing Systems Inc.
1295 29th Ave. S.W.
Pompano Beach
33069
UNITED STATES