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Health product recall

Labsscreen Multi

Starting date:
April 19, 2017
Posting date:
May 16, 2017
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-63300

Reason

The LabScreen multi instruction for use (LM-MUTR-PI REV 8, released April 20, 2016) incorrectly states the capability to use the LabScan 3D instrument in conjunction with the LabScreen multi product.

Affected products

Labsscreen Multi

Lot or serial number

Lot# 007 - Batch# 0000091458
Lot# 007 - Batch# 0000099706
Lot# 007 - Batch# 0000145845

Model or catalog number

LSMUTR

Companies

Manufacturer
One Lambda Inc
21001 Kittridge Street
Canoga Park
91303-2801
California
UNITED STATES