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