FDA Medical Device Recalls (openFDA)
Siemens Healthcare Diagnostics: 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.
- Recall number
- Z-0646-2013
- Recalling firm
- Siemens Healthcare Diagnostics
- 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.
- Status
- Terminated
- Initiated
- 2012-11-28
- Posted
- 2013-01-07
- Terminated
- 2013-10-28
- Reason
- 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)
- Root cause
- 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
- Lot 969=33 units (29 units foreign) Lot 970=7 units (42 units foreign)
- 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,
- Lot, serial or model codes
- Lots 969 and 970
- 510(k) numbers
- ["K872305"]
- PMA numbers
- not on file
- Product code
- JLW
- Firm FEI
- 2432235
- Firm city
- Tarrytown
- Firm state
- NY
- Firm country
- not on file
Where this comes from
- Register
- FDA Medical Device Recalls (openFDA)
- Publisher
- U.S. Food and Drug Administration (openFDA)
- File
- device-recall-0001-of-0001.json.zip
- sha256
- b87518bfe2e8
- Size
- 288210821 bytes
- Published
- 2026-09-28
- Read
- 2026-09-29T08:25:23.626Z
- Source file
- Source file retained · verify
- Refresh due
- 2026-10-06
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Cite as
FDA Medical Device Recalls (openFDA) (U.S. Food and Drug Administration (openFDA)), device-recall-0001-of-0001.json.zip, sha256 b87518bfe2e8, published 2026-09-28