Siemen's Healthcare Diagnostics Unit Recalls MicroScan Synergies plus, rapID/S plus Gram Negative Panels

Siemens Healthcare Diagnostics (NYSE: SI) has issued a voluntary recall of itsMicroScan Synergies plus^® Negative and rapID/S plus Negative panels. Thesepanels are used for determining antimicrobial susceptibility and/oridentification for gram-negative bacteria. An internal investigation hasconfirmed an increase in false susceptible and false intermediate misreads forimipenem and/or meropenem when read rapidly (< 16 hours) on the MicroScan^®WalkAway Microbiology System¹. The investigation determined that no otherantimicrobial agent results are affected. Siemens has notified the FDA of thisaction.This defect could potentially lead to misclassification of a resistant orpartially resistant strain of gram negative bacteria which may result intreatment with an inappropriate antibiotic or a delay in initiatingappropriate therapy. As a result of these findings, Siemens has issued avoluntarily recall for MicroScan Synergies plus Negative and rapID/S plusNegative panels shipped from June 2011 through August 2013. This issue is notpanel lot specific or related to a particular WalkAway instrument model. DriedOvernight Gram Negative Panels are not impacted by the issue.The following panels have been affected by this issue: SiemensDescription     Material     Part Number     Distribution Number (SMN) Brazil, China,Neg Combo Panel Colombia. Germany,Type 2 (SI+NC2)     10444747     B1025-108     India, Mexico, Peru, Russia, South Africa, Thailand, United StatesNeg/Urine Combo Canada, China,Panel Type 1     10444745     B1025-106     Colombia, United States(SI+NUC1) Algeria, Brazil,Neg/Urine Combo Colombia, Italy,Panel Type 2     10444749     B1025-112     Mexico, Romania,(SI+NUC2) Russia, Spain, United StatesNeg/Urine ComboPanel Type 5     10483101     B1025-115     United States(SI+NUC5) Algeria, India, Iraq, Kazakhstan, Malaysia,Neg Breakpoint Mexico, Oman, Poland,Combo Panel Type     10444748     B1025-109     Qatar, Romania, Russia,7 (SI+NBPC7) Saudi Arabia, Spain, Thailand Turkey, United Arab Emirates, United States, UruguayNeg Combo Panel     10444600     B1016-201     None*Type 3 (SI+NC3)Neg/Urine ComboPanel Type 4     10444601     B1016-202     None*(SI+NUC4)Neg Breakpoint Austria, GermanyCombo Panel Type     10460272     B1016-203     Romania8 (SI+NBPC8)Neg Combo Type     10444792     J1025-311     Japan3.11 (R+NC3.11)Neg Combo Type     10444793     J1025-312     Japan3.12 (R+NC3.12)Neg MIC Type     10444794     J1025-333     Japan3.33 (R+NC3.33)* Products are make to order and none were ordered during the recall period. All affected customers have already been notified and instructed, via letterand the addition of Important Product Information (IPI) labeling to the panelboxes, to suppress all Susceptible (S) or Intermediate (I) interpretation andMIC results for imipenem and meropenem with all Synergies plus Negative andrapID/S plus Negative panels, until further notice.Siemens Healthcare Diagnostics has also recommended that customers considerreviewing previous Synergies plus Negative and rapID/S plus Negative testresults from June 2011 through August 2013, conduct patient follow-up, and/orrepeat imipenem and/or meropenem susceptibility testing by another product ormethod, if the isolates are still available.Customers with questions may contact Siemens Healthcare Diagnostics viatelephone at 1-800-677-7226, Option 1 (USA/Canada), Mondays – Fridays 7:00 am– 7:00 pm (EST) and Saturdays, Sundays and holidays 7:30 am – 4:00 pm (EST).