Device Recall CoatACount TSH IRMA IKTS1 with calibrator TSI3X Lot 035 의 리콜

Recall

63852

Class 3

Z-0646-2013

2012-11-28

2013-01-07

Terminated

United States

2013-10-28

USFDA

https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfres/res.cfm?id=114905

The recall was initiated because siemens healthcare diagnostics confirmed an under-recovery of dose values with some vials of coat-a-consta (cac) irma tsh calibrators tsi4 (level b), tsi5 (level c), tsi6 (level d), tsi8 (level f), and tsi9 (level g) lot 035. the affected calibrator vials can be identified by a darker yellow color than normal. the tsi3 (level a), tsi7 (level e), and tsix (level h).

Siemens sent an Urgent Medical Device Recall letter dated November 2012 to all affected customers. The letter identified the product, the problem, and the action to be taken by the customer. Customers were instructed to discontinue use of the affected product, complete and return the Urgent Medical Device Recall Effectiveness Check form included with the letter by fax to 302-631-7597. Customers were also instructed to determine their replacements needed, and to forward the recall letter to whomever they may have distributed the affected product. For questions customers were instructed to contact their Siemens Technical Solutions Ceter or their local technical support representative. For questions regarding this recalla call 914-524-2955.