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Siemens ADVIA Centaur BR Assay: Catalog Number recallZ-0162-2013 · Siemens Healthcare Diagnostics, Inc · initiated Sep 11, 2012

Class II Terminated All recalls posted in October 2012

Is my device affected?

  1. Compare the model, catalog and lot or serial numbers on your device or its packaging with the code information below. A recall usually covers only specific models or lots.
  2. If yours is listed, follow the instructions from Siemens Healthcare Diagnostics, Inc or your healthcare provider. The company's action is summarized under what the company is doing.
  3. Do not stop using a prescribed or implanted device on your own — talk to your healthcare provider first.

Where to find your model and lot numbers · What recall classes and statuses mean

Why it was recalled

BR Assay for CA 27.29 Calibration Interval Change due quality control (QC) results outside of the expected ranges.

FDA root cause category: Under Investigation by firm

What the company is doing

Siemens sent two "URGENT FIELD SAFETY NOTICE" letters dated August and September 2012 to all affected customers. The letters identified the product, problem, and actions to be taken by the customers. A Field Correction Effectiveness Check Form was included for customers to complete and return.

Recall details

Recall number
Z-0162-2013
Recall class
Class II
Status
Terminated
Initiated by the company
Sep 11, 2012
Posted by the FDA
Oct 28, 2012
Recalling firm
Siemens Healthcare Diagnostics, Inc
Quantity
15,455 kits
Product code
MOI
FDA submissions
K982680
Distribution
Worldwide Distribution-USA (nationwide) and the countries of Australia, Brazil, Canada, Columbia, Japan, Korea, Mexico, New Zealand, Peru, Saudi Arabia, and Spain.

Product description

Siemens ADVIA Centaur BR Assay: Catalog Number: US: REF 02419937 (10214722) (50 Tests); REF 03896216(10334837)(250 Tests) Not CE Marked; OUS: REF03204829(10310271)(50 Tests); REF 01157807(1 0314722) (250 Tests) CE Marked; REF 09010686 (10340081)(250 Tests). The ADVIA Centaur BR assay is an in vitro diagnostic test for the quantitative serial determination of cancer antigen CA 27.29 in human serum using the ADVIA Centaur and ADVIA Centaur XP systems. The test is intended for use as an aid in monitoring patients previously treated for Stage II or Stage Ill breast cancer. Serial testing for CA 27.29 in the serum of patients who are clinically free of disease should be used in conjunction with other clinical methods used for the early detection of cancer recurrence. The test is also intended for use as an aid in the management of breast cancer patients with metastatic disease by monitoring the progression or regression of disease in response to treatment.

Code information (models, lots, serial numbers)

BR Assay for CA 27.29 BR Assay Kit Lots ReadyPack¿ Lot Number Ending in 198:. 89291198,86469198,85752198,88939198, 87757198, 85459198, 88319198, 86295198, 85194198  ReadyPack¿ Lot Number Ending in 202:  93573202, 91045202, 93664202, 90880202, 93157202,91126202,90494202.  BR Assay for CA 15-3 ReadyPack BR Assay Kit Lots Lot Number Ending in 199:  87425199,85862199,86949199,85945199

Other devices under the same FDA submission

5 devices cleared under K982680 — the recall does not name any of them by identifier. One submission often covers many models, so they may or may not be affected.

Sources and updates

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