—#130890

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 determining identification to the species level and/or antimicrobial agent susceptibility of rapidly growing aerobic and facultatively anaerobic gram negative bacilli.

FDA product code: LON — System, Test, Automated, Antimicrobial Susceptibility, Short Incubation
Device class: Class 2
Medical specialty: Microbiology
PMA numbers: P870049
Affected lot / code info: 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/

Why it was 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.

Root cause (FDA determination)

Nonconforming Material/Component

Action the firm took

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.

Recalling firm

Firm: Siemens Healthcare Diagnostics, Inc.
Address: 2040 Enterprise Blvd, West Sacramento, California 95691-3427

Distribution

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.

Timeline

Recall initiated: 2014-10-17
Posted by FDA: 2014-11-07
Terminated: 2015-06-29
Status: —

Source: openFDA Device Recall endpoint. Recall record ID #130890. The FDA issues recall classifications as health-hazard assessments, not legal findings; for legal claims consult a licensed attorney.