ADVIA Centaur Folate Ascorbic Acid/Ascorbic Acid Diluent recallZ-2739-2015 · Siemens Healthcare Diagnostics, Inc · initiated Jul 27, 2015
Class II Terminated All recalls posted in September 2015
Is my device affected?
- 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.
- 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.
- 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
Low red blood cell control recoveries and low results for red blood cell patient samples when using the ADVIA Centaur Systems Folate assay.
FDA root cause category: Process design
What the company is doing
An Urgent Medical Device Recall (UMDR) was sent to all affected Siemens Healthcare Diagnostics customers in the United States on July 27, 2015 to be delivered to customers on July 28, 2015. An Urgent Field Safety Notice (UFSN) was sent out for distribution to all customers outside the United States on July 27, 2015. These notices inform the customer to discontinue use of ADVIA Centaur Folate Ascorbic Acid/Ascorbic Acid Diluent kit lots 54942, 56230 and 70673 and dispose of the remaining inventory per local regulations. The ADVIA Centaur Systems Folate red blood cell sample and control negative bias is minimal in the lower range of the assay and is more pronounced with increasing folate concentrations. The negative bias could lead to a misclassification of a patient as folate deficient. Siemens does not recommend a look back of previously tested patients. Fax-back forms will be used to confirm that the customers received the Urgent Medical Device Recall. 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 Recall and completed the required actions.
Recall details
- Recall number
- Z-2739-2015
- Recall class
- Class II
- Status
- Terminated
- Initiated by the company
- Jul 27, 2015
- Posted by the FDA
- Sep 4, 2015
- Recalling firm
- Siemens Healthcare Diagnostics, Inc
- Quantity
- 466
- Product code
- CGN
- FDA submissions
- K010050
- Distribution
- Worldwide Distribution-US (nationwide) including the states of CA CT DE FL GA IA IL IN KS KY MA MD MI MO NJ NM NV NY OH PA RI SC TN TX VA WA WI and OUS: Belgium Estonia Finland France Germany Great Britain Ireland Italy Pakistan Spain Sweden Switzerland Turkey.
Product description
ADVIA Centaur Folate Ascorbic Acid/Ascorbic Acid Diluent; SMN 10316877. Used to prepare the Red Blood Cell hemolysate for use with the ADVIA Centaur systems folate assay.
Code information (models, lots, serial numbers)
Lot Number/Expiration: 54942 2015-11-17; 56230 2015-11-17; 70673 2015-11-17
Other devices under the same FDA submission
3 devices cleared under K010050 — the recall does not name any of them by identifier. One submission often covers many models, so they may or may not be affected.
- ADVIA Centaur® FOL 10310308Siemens Healthcare Diagnostics Inc. · ACID, FOLIC, RADIOIMMUNOASSAY1 recall3 reports
- ADVIA Centaur® FOL 10325366Siemens Healthcare Diagnostics Inc. · ACID, FOLIC, RADIOIMMUNOASSAY1 recall1 report
- ADVIA Centaur® FOL 10331250Siemens Healthcare Diagnostics Inc. · ACID, FOLIC, RADIOIMMUNOASSAY1 recall0 reports
Sources and updates
- Recall record: FDA Medical Device Recalls, file dated Oct 16, 2026 · View the FDA recall notice ↗
- Devices: FDA GUDID, file dated Oct 13, 2026. Devices are linked when their identifier (with a valid check digit) appears in the recall's code information.
- Page last rebuilt: Oct 18, 2026. Text above is shown as published by the FDA.
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