Siemens Recalls MicroScan Synergies plus® and rapID/S plus Gram Negative Panels
Siemens Recalls MicroScan Synergies plus® and rapID/S plus Gram Negative Panels
Siemens recalls specific panels shipped June 2011 through August 2013
TARRYTOWN, N.Y.--(BUSINESS WIRE)-- Siemens Healthcare Diagnostics (NYS: 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.
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).
¹ Editor's note: Product names are specific and should not be abbreviated or shortened.
The Siemens Healthcare Sector is one of the world's largest suppliers to the healthcare industry and a trendsetter in medical imaging, laboratory diagnostics, medical information technology and hearing aids. Siemens offers its customers products and solutions for the entire range of patient care from a single source - from prevention and early detection to diagnosis, and on to treatment and aftercare. By optimizing clinical workflows for the most common diseases, Siemens also makes healthcare faster, better and more cost-effective. Siemens Healthcare employs some 51,000 employees worldwide and operates around the world. In fiscal year 2012 (to September 30), the Sector posted revenue of 13.6 billion euros and profit of around 1.8 billion euros. For further information please visit: www.siemens.com/healthcare.
Siemens Healthcare Diagnostics
Susan Drew, 914-524-2844
susan.drew@siemens.com
Follow us on Twitter at: www.twitter.com/siemenshealth
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