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Advia Centaur CP and Advia Centaur System- Intact PTH Assay (2015-01-14)
- Starting date:
- January 14, 2015
- Posting date:
- January 28, 2015
- 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-43461
Recalled products
- Advia Centaur CP - Intact PTH Assay
- Advia Centaur System - Intact PTH
Reason
There is a printing error in the storage and stability table in the instruction for use (IFU) for ADVIA Centaur Systems Intact Parathyroid Hormone (iPTH) QC material (SMN 10492378) for the following languages: French, Spanish, Greek, Hungarian, Korean and Chinese. Siemens is in the process of revising the affected IFUs ADVIA Centaur Systems Intact Parathyroid Hormone (iPTH) QC material can continue to be used since it has been confirmed that no health risk is present.
Affected products
A. Advia Centaur CP - Intact PTH Assay
Lot or serial number
- 321100685
- 402712255
- 437372965
- 480300296
- 59291315
Model or catalog number
- 10492378
Companies
- Manufacturer
-
Siemens Healthcare Diagnostics Inc.
511 Benedict Ave.
Tarrytown
10591
New York
UNITED STATES
B. Advia Centaur System - Intact PTH
Lot or serial number
- 321100685
- 359291315
- 402712255
- 437372965
- 480300296
Model or catalog number
- 10492378
Companies
- Manufacturer
-
Siemens Healthcare Diagnostics Inc.
511 Benedict Ave.
Tarrytown
10591
New York
UNITED STATES