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Health product recall

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