Siemens Calibrator E; SMN 10309079 (2 pack), SMN 10321075 (6 pack), SMN 10335532 (6 pack Ref)

FDA device recall Z-0164-2015 · posted 2014-12-16 · Terminated

Recall details

Recalling firm

Siemens Healthcare Diagnostics, Inc

Reason for recall

Positive bias for Calibrator E lot kits ending in 38 and 39 with the ADVIA Centaur Systems Cortisol and Progesterone assays compared to the respective master curves.

Action taken

An Urgent Medical Device Correction (UMDC) was sent to all affected Siemens Healthcare Diagnostics customers in the United States on September 26, 2014. An Urgent Field Safety Notice (UFSN) was sent out for distribution to all customers outside the United States on September 26, 2014. These notices inform the customer of the positive bias with ADVIA Centaur Systems Cortisol and Progesterone when calibrated with Calibrator E kit lots ending in 38 and 39.Customers may continue use of the affected lots as the clinical utility of the assay is not impacted. The communications also provide information on the performance of the assays when they use Calibrator E kit lots ending in 40. The notices should be reviewed with the facility's laboratory or Medical director. All affected domestic customers were sent a hard copy of the Urgent Medical Device Correction via Federal Express. Fax-back forms will be used to confirm that the customers received the UMDC. For those customers that do not return a fax-back form, a Siemens representative will follow up with those customers to ensure they received the Urgent Medical Device Correction and completed the required actions. All affected customers outside the US will be provided a copy of the Urgent Field Safety Notice via hard copy, e-mail, and/or fax as determined by each country's local regulations and procedures. Each customer will be required to return a completed confirmation fax-back to Siemens. For those customers that do not return a fax-back form, a Siemens representative will follow up with those customers to ensure they received the Urgent Field Safety Notice and completed the required actions.

Root cause

Device Design

Status

Terminated

Product code

JIX

Quantity affected

Total = 19,352 (13,881 - 2 pack, 4878 - 6 pack, 593 - 6 pack REF)

Distribution

Nationwide including Puerto Rico. Worldwide: Afghanistan, Armenia, Austria, Bahrain, Belgium, Bulgaria, Burkina Faso, Canary Islands, Croatia, Cyprus, Czech Republic, Denmark, Estonia, Finland, France

Date initiated

2014-09-26

Date posted

2014-12-16

Date terminated

2016-01-29

Location

East Walpole, MA

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