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Terminated

ADVIA Chemistry A1c_3 CAL (Calibrator) for use on the ADVIA Chemistry Systems, REF/Catalog Number/Siemens Material Number (SMN) 10491408, IVD ADVIA Chemistry A1c_3 Calibrator Information: For in vitro diagnostic use in the calibration of A1c_3 (A1c_3 and A1c_3M) and Total Hemoglobin_3 (tHb_3 and tHb_3M) methods on ADVIA Chemistry systems. The ADVIA Chemistry systems are automated, clinical chemistry analyzers that can run tests on human serum, plasma, or urine in random access and batch modes for in vitro diagnostic use.

FDA Recall Z-2643-2014 · Posted 2014-09-15

Recalling FirmSiemens Healthcare Diagnostics
Recall StatusTerminated
Product CodeJIX
Date Initiated2014-08-06
Date Terminated2017-02-28
Product QuantityDomestic: 1122 kits; Foreign: 236 kits

Reason for Recall

The ADVIA Chemistry Systems A1c_3 method may exhibit a percent bias of -9% to +11% for hemoglobin (Hb)A1c samples when using A1c_3 Calibrator lots 3HD044 and 3LD068. Depending on quality control limits, this issue may not have been detected. NOTE: The percent bias range is a percentage of the HbA1c result. It is NOT absolute HbA1c units.

Firm Action

Siemens sent an Urgent Field Safety Notice dated August 2014 to all affected consignees on August 6, 2014 via Federal Express. The letter instructed consignees to discontinue use and discard calibrator lots 3HD044 and 3LD068. Customers were requested to complete and return the Effectiveness Check questionnaire attached to the Urgent Medical Device Correction letter within thirty (30) days. Distribution of the Urgent Field Safety Notices to foreign consignees was determined at the country level. For questions regarding this recall call 914-524-2955.

Root Cause

Software design

Distribution Pattern

Worldwide Distribution - USA (nationwide) and Internationally to Argentina, Austria, Brazil, Canada, China, Colombia, Croatia, Cyprus, Denmark, Estonia, Finland, France, Germany, Greece, Guatemala, India, Indonesia, Istanbul, Italy, Lithuania, Mexico, Paraguay, Peru, Poland, Romania, Russian Federation, Serbia, Singapore, Slovakia, South Korea, Spain, Switzerland, Thailand, Uruguay, Vietnam, and Zambia.

Related FDA 510(k) Records

Devices referenced by this recall via K-numbers.

K081895ADVIA CHEMISTRY HEMOGLOBIN A1C, ADVIA CHEMISTRY A1C CALIBRATORSSiemens Medical Solutions Diagnostics · 2009-01-08

Official Source

View FDA Recall →

Source: FDA Enforcement Report / Recall database. Always confirm against the official FDA record.

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