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 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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