FDA Device Recall Z-0170-2015: Siemens Healthcare Diagnostics, Inc.

Recall Parameters & Description

Normalized public record details for FDA recall code Z-0170-2015.

Recall Res Number

Z-0170-2015

Recalling Firm / Manufacturer

Siemens Healthcare Diagnostics, Inc.

FEI Number

2919016

Recall Status

Terminated

Recall Classification

N/A

Date Initiated

2014-10-17

Date Posted

2014-11-07

Date Terminated

2015-06-29

Product Code

LON

Event Number

69540

Product Quantity

1381

Product Description 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.

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.

Action Details Customer Recall notification letters were sent on October 17, 2014. Letters recommend that any remaining inventory be discarded and that consideration be given to reviewing previous test result, conduct patient follow up and/or repeat testing if isolates are still available. A second letter clarifying the recall was issued November 7, 2014 which provided additional information as requested by CDRH.

Distribution Pattern 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.

Code Information / Serial Numbers 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.

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Medical Device Recall: Z-0170-2015

Recall Parameters & Description

Related Establishments / Registrations

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