Siemens Recalls MicroScan Synergies plus® and rapID/S plus Gram Negative Panels

  Siemens Recalls MicroScan Synergies plus® and rapID/S plus Gram Negative

  *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

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        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
                                                       Algeria, Brazil,
Neg/Urine Combo                                        Colombia, Italy,
Panel Type 2       10444749        B1025-112     Mexico, Romania,
(SI+NUC2)                                              Russia, Spain, United
Neg/Urine Combo
Panel Type 5       10483101        B1025-115     United States
                                                       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*
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

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:


Siemens Healthcare Diagnostics
Susan Drew, 914-524-2844
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