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ABX Pentra Calcium CP Reagent (2013-09-12)
- Starting date:
- September 12, 2013
- Posting date:
- October 28, 2013
- 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-36453
Recalled Products
ABX Pentra Calcium CP Reagent
Reason
During QC testing, the other equipment manufacturer (OEM) discovered precipitates in some of the R2 reagent casettes of the ABX Pentra Calcium CP (A11A01633) from the lot #: 014664503. The initial functional tests, conducted by the OEM, indicate there is currently no effect on patient results. However, in a previous lot, the OEM did identify aberrant results related to the presence of these precipitates. Therefore, with time, there may be an increase in the quantity of precipitates and by extension a risk of incorrect patient results being reported.
Affected products
ABX Pentra Calcium CP Reagent
Lot or serial number
- 014664503
Model or catalog number
- A11A01633
Companies
- Manufacturer
-
Horiba ABX, Parc Euromedecine
rue Du Caducee - BP 7290, Cedex 4,
Montpellier
34184
FRANCE