Device Recall VITROS AntiHBS Reagent Pack 의 리콜

Recall

64739

Class 3

Z-1161-2013

2012-11-01

2013-04-23

Terminated

United States

2017-03-30

USFDA

https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfres/res.cfm?id=116884

Ortho clinical diagnostics is recalling certain lots of the vitros anti-hbs reagent packs an inability to obtain a valid calibration.

Ortho Clinical Diagnostics (OCD) sent an Urgent Product Correction Notification letter dated November 1, 2012, to all affected customers via USPS. The letter identified the product the problem and the action needed to be taken by the customer. Customers were instructed to discontinue and discard any remaining recalled lots of VITROS Anti-HBS Reagent Packs. Foreign affiliates were informed by email on November 1, 2012, of the issue and instructed to notify their consignees of the issue and actions . On March 22, 2013, OCD sent customer letters via FedEX overnight and/or via USPS to US consignees for two additional lots of product being recalled. The letter provided similar recall instructions as the initial notification. Ortho Clinical Diagnostics has requested that their clients discontinue and discard any remaining inventory of VITROS Anti-HBS Reagent Packs subject to this recall. OCD has also requested that recall product recipients also complete a Confirmation of Receipt and return that document to OCD, fax to: 1-888-557-3759 or 585-453-4110. We apologize for any inconvenience this may cause your laboratory. If you have technical questions please contact Customer Technical Services at 1-800-421-3311. If you have questions about your replacement order, please call our Customer Service Center at 1-800-828-6316.