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ALERE TESTPACK+PLUS STREP A WITH OBC (2016-05-17)
- Starting date:
- May 17, 2016
- Posting date:
- May 30, 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-58632
Affected products
A. ALERE TESTPACK+PLUS STREP A WITH OBC
Reason
Affected devices contain swabs that are defective. The defective swab shafts are yellow in colour when normally white and can be easily broken if bent. In cases where the swab is broken during sample collection from the throat, a patient's throat may be injured and/or the swab may be swallowed.
Affected products
A. ALERE TESTPACK+PLUS STREP A WITH OBC
Lot or serial number
55331K100
55485K100
57538K100
58123K100
59588K100
Model or catalog number
505715J
Companies
- Manufacturer
-
ALERE MEDICAL CO., LTD.
357 MATSUHIDAI
MATSUDO, CHIBA-KEN
270-2214
JAPAN