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Architect System - Active B12 (HOLOTC) Reagent
- Starting date:
- December 2, 2016
- Posting date:
- December 13, 2016
- 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-61426
Reason
Abbott has identified a lot specific stability issue with both reagent lots 10533UP00 and 10534UP00. As the reagent ages, relative light unit (RLU) values for the calibration curve will decrease causing patient results calculated from this depressed curve to over-recover, potentially resulting in falsely elevated patient results. Controls may not reflect reagent instability as recalibration may result in control values within acceptable ranges.
Affected products
Architect System - Active B12 (HOLOTC) Reagent
Lot or serial number
- 10533UP00
- 10534UP00
Model or catalog number
- 3P24-25
- 3P24-35
Companies
- Manufacturer
-
Abbott GmbH and Co. K.G.
Max Planck Ring 2
Wiesbaden
65205
GERMANY