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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

Business Wire

TARRYTOWN, N.Y. -- September 16, 2013

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).

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.

Contact:

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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