Synchron Systems Amphetamine Reagent, Synchron Systems Barbiturates Reagent & Synchron Systems Opiate (OP) Reagent (2019-07-15)
- Starting date:
- July 15, 2019
- Posting date:
- May 15, 2020
- 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-73073
Last updated: 2020-05-15
Affected Products
- Synchron Systems Amphetamine Reagent
- Synchron Systems Barbiturates Reagent
- Synchron Systems Opiate (OP) Reagent
Reason
Studies indicate that cross-reactivity testing may not meet the claims indicated in the amphetamines chemistry information sheet for methylenedioxyamphetamine (MDA) and phenylephrine.
Affected products
A. Synchron Systems Amphetamine Reagent
Lot or serial number
- M904131 and older.
Model or catalog number
- 475000
Companies
- Manufacturer
-
Beckman Coulter Canada L.P.
7075 Financial Dr
Mississauga
L5N 6V8
Ontario
CANADA
B. Synchron Systems Barbiturates Reagent
Lot or serial number
- M903174 and older.
Model or catalog number
- 475012
Companies
- Manufacturer
-
Beckman Coulter Canada L.P.
7075 Financial Dr
Mississauga
L5N 6V8
Ontario
CANADA
C. Synchron Systems Opiate (OP) Reagent
Lot or serial number
- M904130 and older.
Model or catalog number
- 475024
Companies
- Manufacturer
-
Beckman Coulter Canada L.P.
7075 Financial Dr
Mississauga
L5N 6V8
Ontario
CANADA