Immunoradiometric assay.

FDA device recall Z-0647-2013 · posted 2013-01-07 · Terminated

Recall details

Recalling firm

Siemens Healthcare Diagnostics

Reason for recall

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)

Action taken

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.

Root cause

Nonconforming Material/Component

Status

Terminated

Product code

JLW

Quantity affected

Lot 831=19 units (all foreign consignees) and Lot 832=2 units (all foreign consignees)

Distribution

Worldwide Distribution - USA including CA, GA, IL, IN, MI, MN, NY, and Puerto Rico. Internationally to Agentina, Bolivia, Brazil, Canada, Chile, Guatemala, South Korea, Philippines, Paraguay, Taiwan,

Date initiated

2012-11-28

Date posted

2013-01-07

Date terminated

2013-10-28

Location

Tarrytown, NY

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