FDAClass INovember 19, 2014

Rapid Neg Urine Combo Panel Type 1 recall

Rapid Neg Urine Combo Panel Type 1; Catalog number B 1017-167; Siemens Material Number 10444652 MicroScan Rapid panels are designed for use in…

Why was Rapid Neg Urine Combo Panel Type 1 recalled?

An increase in false positive susceptible results on Rapid Neg BP Combo Panel Type 3 and Rapid Neg Urine Combo Panel Type 1 used with MicroScan Microbiology Systems.

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?

Catalog number: B1017-167, Siemens Material number 1044652, lot numbers: 2014-11-01, Exp. 2014-11-01; 2015-01-03, Exp 2015-01-03; 2015-02-14, Exp 2015-02-14; 2015-03-21, Exp 2015-03-21; 2015-05-20, Exp 2015-05-20; 2015-06-18, Exp 2015-06-18; 2015-07-18, Exp 2015-07-18; 2015-08-11, Exp 2015-08-11/

Product
Rapid Neg Urine Combo Panel Type 1; Catalog number B 1017-167; Siemens Material Number 10444652 MicroScan Rapid panels are designed for use in…
Recalling firm
Siemens Healthcare Diagnostics, Inc.
Quantity
2239
Distribution
Distributed US (nationwide) including the states of IA, CA, NY, WI, MI, SD, NC, FL, HI, OH, WA, TX, WA, IN, NM, MS, KY, IL, UT, ND, and WY and the country of Canada.
Recall date
November 19, 2014
Classification
Class I
Status
Terminated
Agency
FDA (device)
Open FDA enforcement record Latest recalls