Siemens Healthcare Diagnostics Recall: Immunoradiometric assay. Device is an immunoradiome
Siemens Healthcare Diagnostics Recall: Immunoradiometric assay. Device is an immunoradiome is one of 9,000 recalls in the RecallGuard dataset. Key details — Recalling firm: Siemens Healthcare Diagnostics; Product: Immunoradiometric assay. Device is an immunoradiometric assay designed for the quantitative measurement of
| 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. |
| 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) |
| Classification | Class III (least serious — unlikely to cause adverse health consequences) |
| Status | Terminated |
| 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, |
| Recall initiated | 20121128 |
| Recall number | Z-0648-2013 |
| Category | device |
| State | NY |
| Country | United States |
$29/mo
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