Z-2899-2016Class II

Siemens ADVIA Centaur Calibrator U, For in vitro diagnostic use in calibrating the following assays using...

Name: Z-2899-2016 Siemens ADVIA Centaur Calibrator U, For in vitro diagnostic use in calibrating the following assays using...
Creator: Siemens Healthcare Diagnostics, Inc
Published: 2016-08-08
License: https://open.fda.gov/license/

Siemens Healthcare Diagnostics Inc. / initiated 2016-08-08 / Terminated / root cause: manufacturing process

FDA source

Siemens Healthcare Diagnostics, Inc began a recall of Siemens ADVIA Centaur Calibrator U, For in vitro diagnostic use in calibrating the following assays using ADVIA Centaur"' systems: Myoglobin cTnl Cat No. ADVIA... on 2016-08-08. FDA classified it as Class II and gives the reason as "Failure of analytical sensitivity with Calibrator U kit lots ending in 63 and 64 and a drift from the internal standardization". As of 2026-09-10, the recall status on record is Terminated, and MDM tags the root cause as manufacturing process.

Recall record

Recall number: Z-2899-2016
Classification: Class II
Status: Terminated
Initiated: 2016-08-08
Posted: 2016-09-28
Terminated: 2018-10-03
Recalling firm: Siemens Healthcare Diagnostics Inc.
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)
Product code: DDR Myoglobin, Antigen, Antiserum, Control
Reason for recall: Failure of analytical sensitivity with Calibrator U kit lots ending in 63 and 64 and a drift from the internal standardization
Root cause tag: manufacturing process
FDA root cause: Nonconforming Material/Component
Action: Siemens Healthcare Diagnostics issued an Urgent Medical Device Correction (UMDC) to customers in the US on August 8, 2016, to be delivered to customers on August 9, 2016. An Urgent Field Safety Notice (UFSN) was sent out for distribution to all customers outside the United States on August 8, 2016. The communications notify customers of the failure of analytical sensitivity with Calibrator U kit lots ending in 63 and 64 and a drift from the internal standardization. The communications also inform customers that analytical sensitivity and alignment to the internal standardization will be restored with the release of Calibrator U kit lots ending in 65. Customers may continue to use Calibrator U lots CU63 and CU64 with any indate reagent kit lot, current QC ranges and current Master Curve Material lot 45719. Revised QC targets and ranges are located on the Bio-Rad website at QCnet.com for use with CU65 and higher. For further questions, please call (508) 668-5000.
Quantity in commerce: 2,248 kits
Distribution: Worldwide Distribution - Nationwide Distribution including the countries of: Argentina Australia Brazil Canada Chile China Ecuador India Japan Korea Mexico Malaysia Peru Philippines Saudi Arabia Singapore Taiwan Vietnam South Africa
Product codes and lots: Kit Lots ending in 63 and 64 as follows: 65710A63, 77825A63, 99481A64, 08835A64, 22955A64

Enforcement reports

One row per recalled product line

FDA enforcement reports joined to recall event Z-2899-2016
Recall number	Class	Status	Voluntary or mandated	Report date	Classified
Z-2899-2016	Class II	Terminated	Voluntary: Firm initiated	2016-10-05	2016-09-28

Product code DDR

K122599Class IIAdvia Chemistry Myoglobin Reagent, Advia Chemistry Myoglbin CalibratorSiemens Healthcare Diagnostics, Inc. / cleared 2012-10-03

MDM coverage of this record lists here, newest first.

About this record

Sourced from the FDA device recall database and the FDA enforcement reports, both ingested from openFDA. The recall record supplies the product, the reason and the product code; the enforcement report supplies the classification. The two datasets are exported by FDA on different days, and the date above is the older of the two, so nothing on this page is newer than it says.

MDM adds the root cause tag, derived from FDA’s own root cause text, and the cross-links to the product code, the clearances named on the record and MDM coverage. Where a recall has not been joined to an enforcement report, no classification is shown.

Data as of 2026-09-30, the FDA export date for this dataset. Page last changed 2026-09-05. View this recall on fda.gov (opens on fda.gov)