Important Safety Alerts

Medical device manufacturer, Abbott, has issued medical device safety alerts concerning its MULTIGENT Lithium assay and Alinity c Lithium Reagent Kit. The affected devices are identified as follow:

• Product Name: A) MULTIGENT Lithium ; B) Alinity c Lithium Reagent Kit
• List Number: A) 8L25‐30; B) 08P5320
• Lot Number (Expiration Date) : A) 71175Y600 (31Oct2019), 80362Y600 (31Jan2020), 80201Y600 (31Jan2020), 80533Y600 (30Jun2020), 80463Y600 (30Jun2020), 80424Y600 (30Jun2020), 80605Y600 (30Sep2020), 90208Y600 (31Jan2021); B) 80553Y600 (31Jul2019), 80444Y600 (31Jul2019), 80625Y600 (30Nov2019), 90224Y600 (29Feb2020)

Abbott has received Field Safety Notices (FSNs) from Sentinel Diagnostic (the manufacturer of the affected products) to inform of the affected products have been updated with an additional SmartWash parameter to prevent the potential for carryover from the ARCHITECT Lactate Dehydrogenase (LDH) reagent (LN 2PS6) and the Alinity c Lactate Dehydrogenase (LDH) Reagent Kit (LN 07P74).

Carryover may be observed between the affected products and the LDH reagents (i.e. LN 2PS6 or LN 07P74) on improperly maintained systems due to the presence of lithium lactate in the LDH reagents.

According to the manufacturer, there is a potential to generate falsely elevated lithium patient results. To minimize the potential for carryover, an additional SmartWash has been implemented for the MULTIGENT or Alinity c Lithium assays.

Affected customers are advised to take the following actions:

• For MULTIGENT Lithium, if the laboratory does not have the LDH reagent installed on the system, no action is required. If the LDH reagent is installed on the instrument, update the affected product assay parameters to add the new SmartWash. For additional information, see the ARCHITECT System Operations Manual, Section 2, Configure the SmartWash settings (c System). For information on maintaining optimal system performance, refer to the ARCHITECT System Operations Manual.
• For Alinity c Lithium Reagent Kit, install the Alinity c Lithium assay file version 6 to implement the new LDH SmartWash. For information on maintaining optimal system performance, refer to the Alinity ci-series Operations Manual.
• Review the content of the FSNs with the Medical Director and retain the FSNs for the laboratory records or any further reference.

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 July 2019