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Ortho Reagent Red Blood Cell Products (2016-11-01)
- Starting date:
- November 1, 2016
- Posting date:
- November 18, 2016
- 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-61160
Affected Products
- Reagent Red Blood Cells Selectogen
- Reagent Red Blood Cells (Pooled Cells) Affirmagen
- Reagent Red Blood Cells (Pooled Cells) Ortho Coombs Control
- Resolve Panel A
- Resolve Panel B
- Reagent Red Blood Cells Surgiscreen
- ORTHO Confidence System
- Reagent Red Blood Cells ORTHO Ficin Panel System Resolve Panel C Untreated
- Reagent Red Blood Cells 0.8% Selectogen
- Reagent Red Blood Cells 0.8% Surgiscreen
- Reagent Red Blood Cells Ortho 0.8% Pooled Screening Cells
- Reagent Red Blood Cells 0.8% Resolve Panel A
- Reagent Red Blood Cells 0.8% Resolve Panel B
- Reagent Red Blood Cells (Pooled Cells)
- Reagent Red Blood Cells 0.8% AFFIRMAGEN
- Reagent Red Blood Cells 0.8% AFFIRMAGEN 3
- Reagent Red Blood Cells 0.8% Resolve Panel C System
Reason
Ortho Clinical Diagnostics (Ortho) has initiated this recall due to an increase in customer complaints. Ortho has confirmed the intermittent presence of marked hemolysis in Ortho Reagent Red Blood Cell (RRBC) products as well as quality control products containing red blood cells.
Ortho conducted an extensive investigation, and the root cause for the marked hemolysis has been identified as microbial contamination.
Affected products
A. Reagent Red Blood Cells Selectogen
Lot or serial number
- S928
- S934
- S937
- S938
Model or catalog number
- 719610
Companies
- Manufacturer
-
Ortho-Clinical Diagnostics Inc.
1001 US HWY 202
Raritan
08869
UNITED STATES
B. Reagent Red Blood Cells (Pooled Cells) Affirmagen
Lot or serial number
More than 10 numbers, contact manufacturer.
Model or catalog number
- 719210
Companies
- Manufacturer
-
Ortho-Clinical Diagnostics Inc.
1001 US HWY 202
Raritan
08869
UNITED STATES
C. Reagent Red Blood Cells (Pooled Cells) Ortho Coombs Control
Lot or serial number
More than 10 numbers, contact manufacturer.
Model or catalog number
- 719810
Companies
- Manufacturer
-
Ortho-Clinical Diagnostics Inc.
1001 US HWY 202
Raritan
08869
UNITED STATES
D. Resolve Panel A
Lot or serial number
- RA038
- RA039
- RA040
- RA041
- RA042
- RA043
Model or catalog number
- 719510
Companies
- Manufacturer
-
Ortho-Clinical Diagnostics Inc.
1001 US HWY 202
Raritan
08869
UNITED STATES
E. Resolve Panel B
Lot or serial number
- RB451
- RB452
- RB453
- RB455
- RB456
- RB457
- RB458
Model or catalog number
- 719520
Companies
- Manufacturer
-
Ortho-Clinical Diagnostics Inc.
1001 US HWY 202
Raritan
08869
UNITED STATES
F. Reagent Red Blood Cells Surgiscreen
Lot or serial number
More than 10 numbers, contact manufacturer
Model or catalog number
- 719100
Companies
- Manufacturer
-
ORTHO-CLINICAL DIAGNOSTICS INC.
1001 US HWY 202
Raritan
08869
New Jersey
UNITED STATES
G. ORTHO Confidence System
Lot or serial number
- CNF031
- CNF032
- CNF035
- CNF036
- CNF037
- CNF028
- CNF029
Model or catalog number
- 6902096
Companies
- Manufacturer
-
Ortho-Clinical Diagnostics Inc.
1001 US HWY 202
Raritan
08869
UNITED STATES
H. Reagent Red Blood Cells ORTHO Ficin Panel System Resolve Panel C Untreated
Lot or serial number
- RC450
- RC451
- RC452
- RC453
- RC454
Model or catalog number
- 719410
Companies
- Manufacturer
-
Ortho-Clinical Diagnostics Inc.
1001 US HWY 202
Raritan
08869
UNITED STATES
I. Reagent Red Blood Cells 0.8% Selectogen
Lot or serial number
More than 10 numbers, contact manufacturer.
Model or catalog number
- 6902315
Companies
- Manufacturer
-
Ortho-Clinical Diagnostics Inc.
1001 US HWY 202
Raritan
08869
UNITED STATES
J. Reagent Red Blood Cells 0.8% Surgiscreen
Lot or serial number
More than 10 numbers, contact manufacturer.
Model or catalog number
- 6902316
Companies
- Manufacturer
-
Ortho-Clinical Diagnostics Inc.
1001 US HWY 202
Raritan
08869
UNITED STATES
K. Reagent Red Blood Cells Ortho 0.8% Pooled Screening Cells
Lot or serial number
- VP224
- VP225
- VP226
Model or catalog number
- 6902314
Companies
- Manufacturer
-
Ortho-Clinical Diagnostics Inc.
1001 US HWY 202
Raritan
08869
UNITED STATES
L. Reagent Red Blood Cells 0.8% Resolve Panel A
Lot or serial number
- VRA255
- VRA256
- VRA257
- VRA258
- VRA259
- VRA260
Model or catalog number
- 6902317
Companies
- Manufacturer
-
Ortho-Clinical Diagnostics Inc.
1001 US HWY 202
Raritan
08869
UNITED STATES
M. Reagent Red Blood Cells 0.8% Resolve Panel B
Lot or serial number
- VRB222
- VRB223
- VRB224
Model or catalog number
-
6902318
Companies
- Manufacturer
-
Ortho-Clinical Diagnostics Inc.
1001 US HWY 202
Raritan
08869
UNITED STATES
N. Reagent Red Blood Cells (Pooled Cells)
Lot or serial number
- A2627
- A2629
- A2630
- A2632
- A2634
Model or catalog number
- 719310
Companies
- Manufacturer
-
Ortho-Clinical Diagnostics Inc.
1001 US HWY 202
Raritan
08869
UNITED STATES
O. Reagent Red Blood Cells 0.8% AFFIRMAGEN
Lot or serial number
More than 10 numbers, contact manufacturer.
Model or catalog number
- 719201
Companies
- Manufacturer
-
Ortho-Clinical Diagnostics Inc.
1001 US HWY 202
Raritan
08869
UNITED STATES
P. Reagent Red Blood Cells 0.8% AFFIRMAGEN 3
Lot or serial number
- 83A291
- 83A289
- 83A290
Model or catalog number
- 719211
Companies
- Manufacturer
-
Ortho-Clinical Diagnostics Inc.
1001 US HWY 202
Raritan
08869
UNITED STATES
Q. Reagent Red Blood Cells 0.8% Resolve Panel C System
Lot or serial number
- VRC223
- VRC224
- VRC225
- VRC226
Model or catalog number
- 6902319
Companies
- Manufacturer
-
Ortho-Clinical Diagnostics Inc.
1001 US HWY 202
Raritan
08869
UNITED STATES