Access Ostase Calibrators and Access Ostase QC Kits 의 안전성 경고

Safety alert

2015-11-30

2015-11-30

Hong Kong

DH

https://www.mdco.gov.hk/english/safety/recalls/recalls_20151130a.html

Medical device safety alert: beckman coulter access ostase calibrators and access ostase qc kits medical device manufacturer, beckman coulter, has issued a medical device safety alert concerning its access ostase calibrators and access ostase qc kits. the affected products are identified as follows: access ostase calibrators reference: 37305 lot number: 528936 [expiry date: 09-dec-15]; 528938 [expiry date: 13-jan-16] access ostase qc kits reference: 37309 lot number: 528937 [expiry date: 09-dec-15]; 528939 [expiry date:13-jan-16] according to the manufacturer, the access ostase calibrator and access ostase qc lots listed above do not meet their labeled expiration dates when stored after initial use (open vial stability). when stored unopened, calibrators and quality controls are stable until the expiration date on the vials. through internal testing, the manufacturer has determined that the above lots are stable at 2°c to 10°c for 58 days after initial use. an analysis of calibrator and qc open vial stability was performed to determine the percentage shift seen between values obtained at day 58 and the expiration date on the vial. a worst case scenario would result in a 2-4% upward shift above the acceptable 10% allowable shift as compared to the initial, expected value. the manufacturer considers that the magnitude of the deviation is not expected to alter the interpretation of the results or to have a clinical impact. the manufacturer instructs affected users to take the following actions:- discard any access ostase calibrator or access ostase qc vials of the lots listed above that were first used more than 58 days ago. continue to use any unopened access ostase calibrator or access ostase qc vials until their labeled expiration date or 58 days after initial use, whichever comes first. according to the manufacturer, 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 30 november 2015.