FDAClass IIJune 19, 2013

Siemens brand MicroScan Dried Negative Breakpoint Combo recall

Siemens brand MicroScan Dried Negative Breakpoint Combo 47 panels (B1017-417), SMN #: 10483099), For use in determining quantitative and/or…

Why was Siemens brand MicroScan Dried Negative Breakpoint Combo recalled?

The product has the potential for false negative or delayed reaction for Arginine (ARG) results. In addition, 42 hour identification panel holds may occur due to a weak ARG reaction.

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: 2013-11-13, Exp 11/13/2013.

Product
Siemens brand MicroScan Dried Negative Breakpoint Combo 47 panels (B1017-417), SMN #: 10483099), For use in determining quantitative and/or…
Recalling firm
Siemens Healthcare Diagnostics, Inc.
Quantity
683 units
Distribution
Nationwide Distribution.
Recall date
June 19, 2013
Classification
Class II
Status
Terminated
Agency
FDA (device)
Open FDA enforcement record Latest recalls