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ARCHITECT B12 Reagent Kit (2018-12-20) — recall 59035

Health Canada — Medical Devices · Canada · 2019-01-10 · Type III

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Agency: Health Canada — Medical Devices
Recall identifier: 59035
Date of alert: 2019-01-10
Country / jurisdiction: Canada
Risk level: Type III
Risk type: recall
Product category: Medical devices
Product type: Medical devices

Reported risk: Abbott has identified that the incorrect components, 2 assay diluent bottles (7K61J) or 2 pre-treatment 1 bottles (7K61U), may be present in a portion of batch 91345UI00. Kits that do not contain all correct components cannot be scanned on the architect instrument, an error code will be generated upon loading on the reagent inventory screen (e.g.: error code 0900 or 0201).

Primary source: https://recalls-rappels.canada.ca/en/alert-recall/architect-b12-reagent-kit-2018

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ARCHITECT B12 Reagent Kit (2018-12-20) — recall 59035

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