Safety Alert for Acetaminophen L3K Assay

Safety alert

2016-01-29

2016-01-29

Hong Kong

DH

https://www.mdco.gov.hk/english/safety/recalls/recalls_20160129a.html

Medical device safety alert: sekisui diagnostics acetaminophen l3k assay medical device manufacturer, sekisui diagnostics, has issued a medical device safety alert concerning its acetaminophen l3k assay [list number: 506-10 (lot numbers: 47677, 47694, 47649, 47650, 47662, 47663, 48253, 48385, 48386) and 506-30 (lot numbers: 47695, 48294)] abbott diagnostics has received a field safety notice (fsn) from sekisui, the manufacturer of acetaminophen reagent. according to the fsn, sekisui has investigated complaints related to the formation of crystals in the r2 reagent and/or shift of controls when left on board an automated analyzer. during the investigation, it was determined that when the r2 reagent is exposed to the atmosphere for prolonged periods of time, on board an automated analyzer, crystals may form. sekisui has identified the crystals form a standard component of the reagent. the amount of time to crystalise is dependent on reagent usage, temperature, and length of time on board the analyzer. abbott internal testing has shown that the crystal formation does not impact architect csystem instrument performance. sekisui has made the decision to reduce the expiration date of the acetaminophen l3k reagent, catalogue number 506-10 and 506-30, to 9 months from 18 months due to the findings during the investigation. to date, no impact to patient results has been identified. a review of previously reported patient results is not required, however, if affected users chose to do so, they are instructed to follow their standard laboratory protocol. affected users are advised to take the following actions:- discard all reagent in house with a current expiration date of 2016-09. update the expiration on all remaining kits on hand with the expiration dates provided by the manufacturer. reagent requires a daily (24 hour) calibration. reagent should remain on the abbot architect analyzer for a maximum of 8 days. use a minimum volume of 20ml of r2 reagent at a time, using only 20ml wedges. when adding additional reagent to the analyzer use a new wedge. if crystals are observed within reagent stored on-board, reagent should be discarded and replaced with fresh reagent. 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 29 january 2016.