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Health product recall

Synchron Systems Ammonia (AMM) Reagent(2014-05-01)

Starting date:
May 1, 2014
Posting date:
June 5, 2014
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-39827

Recalled Products

Synchron Systems Ammonia (amm) Reagent

Reason

Beckman Coulter has confirmed that Synchron Systems Ammonia reagent lot M210119 does not maintain shelf life up to the labeled expiration date. As a precautionary measure, Beckman Coulter has also decided to reduce the shelf life from 18 to 12 months for the other identified lots.

Affected products

Synchron Systems Ammonia (amm) Reagent

Lot or serial number

M210119
M210298
M301502
M304444
M306041
M307215
M308079
M310152

Model or catalog number

439770
 

Companies
Manufacturer
Beckman Coulter Inc.
250 S. Kraemer Blvd.
Brea
92821
California
UNITED STATES