CLASS I Device recall · Reported 19 Nov 2014 · FDA Enforcement Report

Rapid Neg BP Combo Panel Type recalled by Siemens Healthcare Diagnostics

Siemens Healthcare Diagnostics is recalling Rapid Neg BP Combo Panel Type 3, distributed nationwide in the US. The recall was initiated on 17 Oct 2014 and the FDA has classified it as Class I.

Check your package

Lot, batch or date codesCatalog number: B1017-117, Siemens Material number 1044632, lot numbers: 2014-12-10, Exp. 2014-12-10; 2015-02-27, Exp 2015-02-27; 2015-06-23, Exp 2015-06-23.

Quantity recalled1381

Stop using the device if the notice says to, and contact the manufacturer or your healthcare provider for the correction or replacement.

Recall details

Recall number: Z-0170-2015
FDA event ID: 69540
Recalling firm: Siemens Healthcare Diagnostics, West Sacramento, CA
Classification: Class I
Status: Terminated
Recall initiated: 17 Oct 2014
FDA classified: 7 Nov 2014
Reported: 19 Nov 2014
Type: Voluntary: Firm initiated
Customers notified by: Letter
Reason category: Other Reasons
Device type: Other Medical Devices

Timeline

17 Oct 2014	Recall initiated by company
7 Nov 2014	Classified by FDA	+21 days
19 Nov 2014	Published in enforcement report	+12 days

Companies usually start a recall weeks before the FDA classifies and publishes it; the gap above is that lag.

Reason for recall

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.

Product as listed by the FDA

Rapid Neg BP Combo Panel Type 3; Catalog number B 1017-117. MicroScan Rapid panels are designed for use in determining identification to the species level and/or antimicrobial agent susceptibility of rapidly growing aerobic and facultatively anaerobic gram negative bacilli.

Where it was distributed

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.

Nationwide California Florida Hawaii Iowa Illinois Indiana Kentucky Michigan Mississippi North Carolina North Dakota New Mexico New York Ohio South Dakota Texas Utah Washington Wisconsin Wyoming

Questions about this recall

Is Rapid Neg BP Combo Panel Type 3 recalled?

Yes. Siemens Healthcare Diagnostics recalled Rapid Neg BP Combo Panel Type 3 on 17 Oct 2014. The recall is Class I and its status is Terminated. Recall number Z-0170-2015.

Why was it 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.

Which lots are affected?

Catalog number: B1017-117, Siemens Material number 1044632, lot numbers: 2014-12-10, Exp. 2014-12-10; 2015-02-27, Exp 2015-02-27; 2015-06-23, Exp 2015-06-23.

Where was it sold?

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.

What should I do if I have it?

Stop using the device if the notice says to, and contact the manufacturer or your healthcare provider for the correction or replacement.

What does Class I mean?

Class I is the most serious FDA recall category: there is a reasonable probability that using the product will cause serious health consequences or death.

Read the official FDA notice · Source record retrieved 21 Sep 2026. The FDA describes openFDA data as unvalidated; the official notice takes precedence. This page reports the record and gives no medical advice.

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