Recall Z-2899-2016— Siemens Healthcare Diagnostics, Inc

Name: FDA recall Z-2899-2016
Creator: U.S. Food and Drug Administration
Published: 2016-08-08

Class II · Terminated

Class II FDA medical device recall by Siemens Healthcare Diagnostics, Inc, initiated 2016-08-08, terminated 2018-10-03. It names one FDA 510(k) clearance: K122599. Product: Siemens ADVIA Centaur¿ Calibrator U, For in vitro diagnostic use in calibrating the following assays using ADVIA Centaur"' systems: Myoglobin cTnl Cat No. ADVIA Centaur Calibrator U (2 Pack) - 03684480 (SMN 1 0309996). Reason: Failure of analytical sensitivity with Calibrator U kit lots ending in 63 and 64 and a drift from the internal standardization.

Recalling firm: Siemens Healthcare Diagnostics, Inc
Classification: Class II
Status: Terminated
Initiated: 2016-08-08
Terminated: 2018-10-03
Firm location: East Walpole, MA, United States

510(k) clearances named in this recall

1 on FDA's record

K122599 — ADVIA CHEMISTRY MYOGLOBIN REAGENT, ADVIA CHEMISTRY MYOGLBIN CALIBRATORSiemens Healthcare Diagnostics, Inc.·cleared 2012-10-03

K-numbers as listed on FDA's Recall Enterprise System record for this event (openFDA device/recall k_numbers). The recall may also cover devices cleared under other submissions not named here.

Product description

Siemens ADVIA Centaur¿ Calibrator U, For in vitro diagnostic use in calibrating the following assays using ADVIA Centaur"' systems: Myoglobin cTnl Cat No. ADVIA Centaur Calibrator U (2 Pack) - 03684480 (SMN 1 0309996)

Reason for recall

Failure of analytical sensitivity with Calibrator U kit lots ending in 63 and 64 and a drift from the internal standardization

Data sourced from openFDA. This site is unofficial and independent of the FDA.