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Health product recall

Tobramycin Calibrators

Starting date:
November 16, 2011
Posting date:
January 9, 2012
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-15124

Reason

Customer complaints have been received concerning a shift in results after beginning the use of Tobramycin Calibrators lots 59281991, 59359468, 59390335 and 59511648.  The internal evaluation has confirmed a lower recovery of controls and cap samples.

Affected products

Tobramycin Calibrators

Lot or serial number

59281991, 59359468, 59390335, 59511648

Model or catalog number

7F93-01

Companies

Manufacturer
Seradyn Inc.