Medical device manufacturer, Abbott, has issued a medical device safety alert concerning its Alinity i Active-B12 products. The affected devices are identified as follows:
- Alinity i Active‐B12 (Holotranscobalamin) Reagent [List Numbers: 09P2625, 09P2635, 3P24‐28, 3P24‐38; Lot Number: 11093UP00, 11095UP00, 11089UP00, 11090UP00]
- Alinity i Active‐B12 (Holotranscobalamin) Calibrators [List Numbers: 09P2602, 3P24‐02; Lot Number: 11096UP00, 902933475, 902933926]
- Alinity i Active‐B12 (Holotranscobalamin) Controls [List Numbers: 09P2611, 3P24‐11; Lot Number: 11094UP00, 902933474]
The manufacturer is informing users of a product recall for the reformulated Alinity i Active‐B12 product. The reformulated Active‐B12 product was launched in August 2020. Initial customer data for the reformulated product indicates a higher bias to the previous formulation than was observed during pre‐launch method comparison testing. There is a potential for incorrect results. Preliminary data has shown a potential for both positive and negative bias to the previous formulation results. The positive bias has been observed near the low end of the measuring range, below 40 pmol/L.
This product recall for the reformulated product is being issued as a precautionary measure while a technical investigation is performed at Abbott. The previous formulation of Active‐B12 continues to be available.
Affected users should take the following actions:
- Immediately discontinue use of, and destroy, any remaining inventory of the lot numbers listed above according to their local guidelines and their laboratory procedures.
- In the event they are currently using or have inventory of the lots listed in the table above, affected users should immediately contact Customer Support of Abbott to order replacement lots of the previous formulation Alinity i Active‐B12 (Holotranscobalamin) Reagent 09P2620, 09P2630, Alinity i Active‐B12 (Holotranscobalamin) Calibrators 09P2601, and Alinity i Active‐B12 (Holotranscobalamin) Controls 09P2610 and use assay file 214 Version 5.
- If affected users need to revert from assay file 214 Version 8 to assay file 214 Version 5, they should contact Customer Service.
- Affected users should review this alert with their Medical Director or Laboratory Management and follow their laboratory protocol regarding the need for reviewing previously reported patient results.
According to the local supplier, the affected products are distributed in Hong Kong.
If you are in possession of the affected products, please contact your supplier for necessary actions.
Posted on 16 November 2020