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ARCHITECT 2ND GENERATION TESTOSTERONE REAGENT (2016-03-09)
- Starting date:
- March 9, 2016
- Posting date:
- March 17, 2016
- 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-57582
Affected Products
ARCHITECT 2ND GENERATION TESTOSTERONE REAGENT
Reason
On February 24, 2016, a product deficiency was identified. Testing performed to investigate complaint ticket 1061060R1715901 (received February 12, 2016) confirmed the issue of obtaining the message "no assay" on the architect module display when using the new assay file and testing with ARCHITECT 2nd Generation Testosterone Reagent Kit, list number 2P13-28, lot 10458UP00. A non-conformance report was opened on 24 Feb 2016. Preliminary root cause investigation was performed by TPM Axis-Shield Diagnostics and identified the barcode for this lot was coded with the us assay file number instead of the OUS assay file number. The information is hardcoded to the barcode on the microparticle bottle. Therefore, the customers are unable to test because the OUS assay file does not recognize this lot with us assay file. Axis shield has both assay files (US and OUS) installed on their analyzer which is why the lot passed testing during manufacturing.
Affected products
ARCHITECT 2ND GENERATION TESTOSTERONE REAGENT
Lot or serial number
10458UP00
Model or catalog number
2P13-28
Companies
- Manufacturer
-
Abbott GmbH and Co. K.G.
Max Planck Ring 2
Wiesbaden
65205
GERMANY