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ARCHITECT STAT HIGH SENSITIVE TROPONIN-I REAGENT KIT (2016-04-28)
- Starting date:
- April 28, 2016
- Posting date:
- May 16, 2016
- 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-58418
Affected Products
ARCHITECT STAT HIGH SENSITIVE TROPONIN-I REAGENT KIT
Reason
To inform customers of a product recall and reduced expiration dating for select ARCHITECT STAT High Sensitive Troponin-I Reagent lots listed in table 1 of the customer letter and to provide instructions on what actions their laboratory must take. Current in-date reagent lots per table 2 of the customer letter will remain at their current expiration date, therefore no further action is required for those current lots.
Affected products
ARCHITECT STAT HIGH SENSITIVE TROPONIN-I REAGENT KIT
Lot or serial number
More than 10 numbers, contact manufacturer.
Model or catalog number
- 3P25-25
- 3P25-26
- 3P25-35
- 3P25-36
Companies
- Manufacturer
-
Abbott Ireland Diagnostics Division
lisnamuck, longford,
IRELAND