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

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Siemens Healthcare Diagnostics (NYSE: SI) has issued a voluntary recall of its MicroScan Synergies plus^® Negative and rapID/S plus Negative panels. These panels are used for determining antimicrobial susceptibility and/or identification for gram-negative bacteria. An internal investigation has confirmed an increase in false susceptible and false intermediate misreads for imipenem and/or meropenem when read rapidly (< 16 hours) on the MicroScan^® WalkAway Microbiology System¹. The investigation determined that no other antimicrobial agent results are affected. Siemens has notified the FDA of this action.

This defect could potentially lead to misclassification of a resistant or partially resistant strain of gram negative bacteria which may result in treatment with an inappropriate antibiotic or a delay in initiating appropriate therapy. As a result of these findings, Siemens has issued a voluntarily recall for MicroScan Synergies plus Negative and rapID/S plus Negative panels shipped from June 2011 through August 2013. This issue is not panel lot specific or related to a particular WalkAway instrument model. Dried Overnight Gram Negative Panels are not impacted by the issue.

The following panels have been affected by this issue:

Siemens Description     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 States Neg/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 States Neg/Urine Combo Panel 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, Uruguay Neg Combo Panel     10444600     B1016-201     None* Type 3 (SI+NC3) Neg/Urine Combo Panel Type 4     10444601     B1016-202     None* (SI+NUC4) Neg Breakpoint Austria, Germany Combo Panel Type     10460272     B1016-203     Romania 8 (SI+NBPC8) Neg Combo Type     10444792     J1025-311     Japan 3.11 (R+NC3.11) Neg Combo Type     10444793     J1025-312     Japan 3.12 (R+NC3.12) Neg MIC Type     10444794     J1025-333     Japan 3.33 (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 letter and the addition of Important Product Information (IPI) labeling to the panel boxes, to suppress all Susceptible (S) or Intermediate (I) interpretation and MIC results for imipenem and meropenem with all Synergies plus Negative and rapID/S plus Negative panels, until further notice.

Siemens Healthcare Diagnostics has also recommended that customers consider reviewing previous Synergies plus Negative and rapID/S plus Negative test results from June 2011 through August 2013, conduct patient follow-up, and/or repeat imipenem and/or meropenem susceptibility testing by another product or method, if the isolates are still available.

Customers with questions may contact Siemens Healthcare Diagnostics via telephone 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).

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