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DRUGCHECK DRUG SCREEN CUP (2016-03-30)
- Starting date:
- March 30, 2016
- Posting date:
- May 31, 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, Hospitals, Healthcare Professionals
- Identification number:
- RA-58694
Affected products
A. DRUGCHECK DRUG SCREEN CUP
Reason
Affected lots of EDIs drugs of abuse tests have shown reduced reactivity for up to three (3) of the nineteen (19) benzodiazepine compounds for which specificity information is provided in the product insert. Specific compounds for which there may be reduced reactivity include clonazepam, nordiazepam and lorazepam. The test continues to perform as expected for other drugs.
Affected products
A. DRUGCHECK DRUG SCREEN CUP
Lot or serial number
- PC-11125
- PC-12141
- PC-12185
- PD-01118
- PD-01119
- PD-01224
- PD-02146
- PD-02214
- PD-02218
- PD-02219
- PD-02268
- PD-02270
- PD-02271
- PD-03054
- PD-03096
- PD-03359
- PD-11015
- PD-11016
- PD-12007
- PD-12073
- PD-12075
- PD-12158
- PD-12262
- PE-01183
- PE-01237
- PE-01242
- PE-01253
- PE-02029
- PE-02030
- PE-02220
- PE-02248
- PE-03185
- PE-03190
- PE-04142
- PE-04143
- PE-05108
- PE-05183
- PE-06018
Model or catalog number
X6XXXXXX
Companies
- Manufacturer
-
Express Diagnostics International, Inc.
1550 INDUSTRIAL DRIVE
BLUE EARTH
56013
Minnesota
UNITED STATES