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Health product recall

BEHRING ELISA PROCESSOR SYSTEM- VARICELLA IGG ENZYGNOST (2015-10-08)

Starting date:
October 8, 2015
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-55650

Affected Products

BEHRING ELISA PROCESSOR SYSTEM- VARICELLA IGG ENZYGNOST

Reason

Siemens Healthcare Diagnostics Products has confirmed that the mentioned Enzygnost Anti-VZV/IgG lots can show a higher variation in homogeneity. This can lead to invalid runs by not meeting the run validation criterion for the reference p/n at the start and end of a series.

Affected products

BEHRING ELISA PROCESSOR SYSTEM- VARICELLA IGG ENZYGNOST

Lot or serial number

44218
44309
44565
45077

Model or catalog number

OWLT15

Companies
Manufacturer
Siemens Healthcare Diagnostics Products Gmbh
Emil-Von-Behring-Str. 76
Marburg
35041
GERMANY