Health product recall

ONLINE DAT Amphetamines II for Roche Hitachi 917 and Modular P Analyzers, ONLINE DAT Amphetamines II For Cobas Integra and Amphetamines II (AMPS2) (2018-08-31)

Starting date:
August 31, 2018
Posting date:
October 5, 2018
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-67874

Affected products

A. ONLINE DAT Amphetamines II for Roche Hitachi 917 and Modular P Analyzers

B. ONLINE DAT Amphetamines II For Cobas Integra

C. Amphetamines II (AMPS2)

Reason

A new cross reactivity was identified for the prodrug Lisdexamphetamin. As a consequence, the following statement will be added in the method sheets of all amphetamine assays: “Lisdexamphetamine is a pharmacologically inactive prodrug of D-Amphetamine. After oral ingestion, Lisdexamphetamine is converted to l-lysine and active D-Amphetamine which may cause a positive test result with this assay.”

Affected products

A. ONLINE DAT Amphetamines II for Roche Hitachi 917 and Modular P Analyzers

Lot or serial number

26609801

29592501

33333001

Model or catalog number

04939425190

Companies
Manufacturer

Roche Diagnostics GMBH

Sandhoferstrasse 116

Mannheim

68305

GERMANY


B. ONLINE DAT Amphetamines II For Cobas Integra

Lot or serial number

24047901

26610601

29594101

Model or catalog number

04512936190

Companies
Manufacturer

Roche Diagnostics GMBH

Sandhoferstrasse 116

Mannheim

68305

GERMANY


C. Amphetamines II (AMPS2)

Lot or serial number

24047201

26609901

29592701

33333101

Model or catalog number

06334385190

Companies
Manufacturer

Roche Diagnostics GMBH

Sandhoferstrasse 116

Mannheim

68305

GERMANY