Retiro De Equipo (Recall) de Tosoh Folate calibrator sets

Recall

36506

Class 3

Z-0082-2007

2006-09-01

2006-10-28

Terminated

United States

2007-07-21

USFDA

https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfres/res.cfm?id=48775

Reports of low calibration rate value flags; use of the recalled product may result in failure to calibrate the instrument.

The firm mailed Urgent: Medical Device Recall letters to their customer accounts on 9/5/2006. The letter informs the customers of the calibration problem and asks that the customers examine their inventories for the presence of the suspect product and place any product found in quarantine. The letter also asks that the customers identify their subaccount/customers and notify them of the recall with a copy of the recall letter, if the product has been further distributed. The recall letter is accompanied by a Response form which the customer is asked to complete and return to TOSOH as soon as possible. The Response form requires reporting of infomation concerning the amount and disposition of all product on-hand. It also includes a section for use by the distributor/customers for indicating whether or not their customers have been notified as well as the names and addressed of the distributor''s subaccounts. Should the customer(s) have any questions, the recall letter provides a telephone number and the name of a contact person to whom questions can be addressed.