FDAClass IIAugust 28, 2019

N Cuvette Segments for BN ProSpec System-IVD a system recall

N Cuvette Segments for BN ProSpec System-IVD a system for the quantitative determination of proteins in serum, plasma, urine and CSF. Siemens Material…

Why was N Cuvette Segments for BN ProSpec System-IVD a system recalled?

Iincreased (falsely elevated) Albumin results compared to expected results

What should I do if I have this product?

Review the official FDA enforcement record for current instructions.

What to do with a recalled product: refunds, receipts, safe disposal and how to report a problem.

Is my product affected?

Compare the item in your hand with every identifier below from the official FDA record. Only products that match the listed product and lot, UPC or model codes are part of this recall.

Which lot codes, UPCs or models are affected?

Lot # 5890128326 and Lot # 182670004 UDI: 00842768012334

Product
N Cuvette Segments for BN ProSpec System-IVD a system for the quantitative determination of proteins in serum, plasma, urine and CSF. Siemens Material…
Recalling firm
Siemens Healthcare Diagnostics, Inc.
Quantity
664 units
Distribution
Nationwide
Recall date
August 28, 2019
Classification
Class II
Status
Terminated
Agency
FDA (device)
Open FDA enforcement record Latest recalls