Ortho Vision Analyzer and Ortho Vision Max Analyzer (2021-03-16)
- Starting date:
- March 16, 2021
- Posting date:
- April 1, 2021
- 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-75295
Last updated:
2021-04-01
Affected Products
- ORTHO VISION ANALYZER
- ORTHO VISION MAX ANALYZER
Reason
A complaint was received from a customer who set up a User Defined Protocol (UDP). When a dispense issue occurred, the result was reported as a negative reaction instead of flagging the result with Wrong Liquid Level (WLL).
Affected products
A. ORTHO VISION ANALYZER
Lot or serial number
- More than 10 numbers, contact manufacturer.
Model or catalog number
- 6904577
Companies
- Manufacturer
-
ORTHO-CLINICAL DIAGNOSTICS INC.
1001 US HWY 202
Raritan
08869
New Jersey
UNITED STATES
B. ORTHO VISION MAX ANALYZER
Lot or serial number
- 70002012
- 70002013
- 70002021
- 70002022
- 70002027
Model or catalog number
- 6904576
Companies
- Manufacturer
-
ORTHO-CLINICAL DIAGNOSTICS INC.
1001 US HWY 202
Raritan
08869
New Jersey
UNITED STATES