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Siemens Healthcare Diagnostics recalls Immunoradiometric assay.
Recalled January 16, 2013 · FDA recall Z-0647-2013 · Siemens Healthcare Diagnostics
Hazard
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 Class III
Units
Lot 831=19 units (all foreign consignees) and Lot 832=2 units (all foreign consignees)
Sold at
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,
Description
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)
Product
Immunoradiometric assay.
Manufacturer(s)
Siemens Healthcare Diagnostics
Source: U.S. Food and Drug Administration. Official recall notice on fda.gov →