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Streptex Latex Agglutination Kit (2013-05-06)
- Starting date:
- May 6, 2013
- Posting date:
- January 24, 2014
- 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-37619
Recalled products
- Streptex Latex Agglutination Kit
Reason
Streptex group D latex may give weak or false negative test results. The positive control reagent continues to react satisfactorily with the latex and will not indicate that the latex reagent is weak.
Affected products
A. Streptex Latex Agglutination Kit
Lot or serial number
- 1154057
- 1192181
Model or catalog number
- RE30950501
Companies
- Manufacturer
-
Remel Inc.
12076 Santa Fe Drive
Lenexa
66215
Kansas
UNITED STATES