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ADVIA Centaur and Centaur CP Systems (2015-01-27)
- Starting date:
- January 27, 2015
- Posting date:
- February 6, 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-43641
Recalled products
- ADVIA Centaur CP System - Progesterone (PRGE) Assay
- ADVIA Centaur System - Progesterone Assay
Reason
There is a high bias on results greater than 30 ng/ml (95.4 nmol/l) when compared to the master curve when using select ADVIA centaur progesterone kit lots. The high bias may cause neat serum samples with results greater than 60 ng/ml (190.8 nmol/l) to recover within the assay range upon dilution (dilution factor applied). Samples with values below 30 ng/ml (95.4 nmol/l) do not demonstrate this bias.
Affected products
A. ADVIA Centaur CP System - Progesterone (PRGE) Assay
Lot or serial number
- 42564268
- 42565268
- 42590268
- 42621268
- 43538268
- 43742268
- 43834268
- 44847268
Model or catalog number
- 01586287
- 02177364
- 02382928
Companies
- Manufacturer
-
Siemens Healthcare Diagnostics Inc.
511 Benedict Ave.
Tarrytown
10591
New York
UNITED STATES
B. ADVIA Centaur System - Progesterone Assay
Lot or serial number
- 42564268
- 42565268
- 42621268
- 42624268
- 43538268
- 43742268
- 43834268
- 44847268
Model or catalog number
- 01586287
- 02177364
- 02382928
Companies
- Manufacturer
-
Siemens Healthcare Diagnostics Inc.
511 Benedict Ave.
Tarrytown
10591
New York
UNITED STATES