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Abbott Realtime High Risk HPV (2014-01-09)
- Starting date:
- January 9, 2014
- Posting date:
- February 11, 2014
- 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-37907
Recalled products
- Abbott Realtime High Risk HPV
Reason
A customer complaint identified a false positive sample result from a run of the Realtime High Risk HPV assay on the M2000RT instrument. Excess instrument noise was present in the reference signals. However no error codes related to excessive noise were generated for any samples in the run.
Affected products
A. Abbott Realtime High Risk HPV
Lot or serial number
All lots
Model or catalog number
- 04N05-01
- 2N09-91
Companies
- Manufacturer
-
Abbott GmbH and Co. K.G.
Max Planck Ring 2
Wiesbaden
65205
GERMANY