| Class 3 Device Recall CoatACount TSH IRMA IKTSX with calibrator TSI3X Lot 035 | |
Date Initiated by Firm | November 28, 2012 |
Date Posted | January 07, 2013 |
Recall Status1 |
Terminated 3 on October 28, 2013 |
Recall Number | Z-0648-2013 |
Recall Event ID |
63852 |
510(K)Number | K872305 |
Product Classification |
Radioimmunoassay, thyroid-stimulating hormone - Product Code JLW
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Product | Immunoradiometric assay.
Device is an immunoradiometric assay designed for the quantitative measurement of thyroid stimulating hormone (thyrotropin, TSH) in serum. It is intended strictly for in vitro diagnostic. Used as an aid in the assessment of thyroid status. |
Code Information |
Lots 742 and 743 |
Recalling Firm/ Manufacturer |
Siemens Healthcare Diagnostics 511 Benedict Ave Tarrytown NY 10591-5005
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For Additional Information Contact | 914-524-2955 |
Manufacturer 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) |
FDA Determined Cause 2 | Nonconforming Material/Component |
Action | 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. |
Quantity in Commerce | Lot 742= 8 units all foreign consignees) Lot 743=7 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, and Uraguay, |
Total Product Life Cycle | TPLC Device Report |
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1 A record in this database is created when a firm initiates a correction or removal action. The record is updated if the FDA identifies a violation and classifies the action as a recall, and it is updated for a final time when the recall is terminated. Learn more about medical device recalls. 2 Per FDA policy, recall cause determinations are subject to modification up to the point of termination of the recall. 3 For details about termination of a recall see Code of Federal Regulations (CFR) Title 21 §7.55.
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510(K) Database | 510(K)s with Product Code = JLW
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