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Health product recall

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