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GASTROCCULT 40T (2016-05-02)
- Starting date:
- May 2, 2016
- Posting date:
- May 16, 2016
- 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-58410
Affected Products
GASTROCCULT 40T
Reason
Beckman Coulter has confirmed an issue where the pH test area for the Gastroccult kit may display an unexpected color for a sample at a pH 7 reading when compared to the associated section of the color comparator bar. A sample with a pH 7 may exhibit a brownish-yellow color reading instead of the expected olive green color. The issue was first reported by a US account in March 2015 but the issue was escalated due to trending observed in January 2016.
Affected products
GASTROCCULT 40T
Lot or serial number
More than 10 numbers, contact manufacturer.
Model or catalog number
- 66040
Companies
- Manufacturer
-
Beckman Coulter, Inc.
250 S. Kraemer Blvd.
Brea
92821
California
UNITED STATES