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:
|Description||Siemens Material Number (SMN)||Part Number||Distribution|
|Neg Combo Panel Type 2 (SI+NC2)||10444747||B1025-108||Brazil, China, Colombia. Germany, India, Mexico, Peru, Russia, South Africa, Thailand, United States|
|Neg/Urine Combo Panel Type 1 (SI+NUC1)||10444745||B1025-106||Canada, China, Colombia, United States|
|Neg/Urine Combo Panel Type 2 (SI+NUC2)||10444749||B1025-112||Algeria, Brazil, Colombia, Italy, Mexico, Romania, Russia, Spain, United States|
|Neg/Urine Combo Panel Type 5 (SI+NUC5)||10483101||B1025-115||United States|
|Neg Breakpoint Combo Panel Type 7 (SI+NBPC7)||10444748||B1025-109||Algeria, India, Iraq, Kazakhstan, Malaysia, Mexico, Oman, Poland, Qatar, Romania, Russia, Saudi Arabia, Spain, Thailand Turkey, United Arab Emirates, United States, Uruguay|
|Neg Combo Panel Type 3 (SI+NC3)||10444600||B1016-201||None*|
|Neg/Urine Combo Panel Type 4 (SI+NUC4)||10444601||B1016-202||None*|
|Neg Breakpoint Combo Panel Type 8 (SI+NBPC8)||10460272||B1016-203||Austria, Germany Romania|
|Neg Combo Type 3.11 (R+NC3.11)||10444792||J1025-311||Japan|
|Neg Combo Type 3.12 (R+NC3.12)||10444793||J1025-312||Japan|
|Neg MIC Type 3.33 (R+NC3.33)||10444794||J1025-333||Japan|
* 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.