Siemens Microscan Synergies Plus Negative Urine Combo 1 Recalled for Misreads
Siemens Healthcare Diagnostics is recalling Microscan Synergies Plus Negative Urine Combo 1 panels due to confirmed false susceptible and intermediate results for imipenem and meropenum.
What this means for you
Real risk of harm even if no illness or injury has been reported yet. Stop using the product and follow the agency's guidance.
Our severity reasoning: The recall involves a medical device that provides diagnostic information for antibiotic susceptibility. Misreads for specific antibiotics represent a risk of harm to patients through potential treatment errors, fitting the 'High' severity criteria for risk-of-harm products where injury has not yet been reported.
Plain-English summary
Siemens Healthcare Diagnostics, Inc. is recalling Microscan Synergies Plus Negative Urine Combo 1 panels. The recall involves 1,209 boxes containing 24,180 panels. The product is used to determine antimicrobial agent susceptibility and identification for gram-negative bacteria.
The recall was initiated due to a confirmed increase in false susceptible and false intermediate misreads for the antibiotics imipenem and meropenum. These misreads occur when the panels are read on the Walk Away System. The affected lots have expiration dates ranging from December 5, 2012, to May 21, 2014.
The product was distributed worldwide, including nationwide in the United States and in numerous international countries. Healthcare facilities and laboratories should stop using the affected panels and contact Siemens Healthcare Diagnostics for instructions on returning the product.
The recalled product
- Product
- Microscan Synergies Plus Negative Urine Combo 1 Product Usage: MicroScan¿ Synergies plus¿ Panels & MicroScan¿ Rapids plus (Negative) - For use in determining quantitative and/or qualitative antimicrobial agent susceptibility and/or identification for gram-negative bacteri
- Manufacturer
- Siemens Healthcare Diagnostics, Inc.
Is your product affected?
Check your packaging against the codes below. If any of them match, the product is part of this recall.
Lot numbers (10)
- Internal Number - B1025-106
- Catalog Number -10444745
- Lot code/expiration date: 2012-12-05
- 2012-12-05
- 2013-01-16
- 2013-02-28
- 2014-01-11
- 2014-02-11
- 2014-05-21
- 2014-05-21.
Distribution
Part of a larger recall action
This product is one of 11 recalled by Siemens Healthcare Diagnostics, Inc. under a single FDA (Devices) recall action. The agency files each product separately, so the size of the action is not visible from this page alone.
See all 11 products in this recall →Related recalls
Same manufacturer · Siemens Healthcare Diagnostics, Inc.
See all →- SevereSiemens Recalls Emit 2000 Quinidine Assay Due to Precision Issues
FDA (Devices) · 2026-08-26
- SevereSiemens Quinidine Assay Recalled for Precision Errors
FDA (Devices) · 2026-08-26
- HighSiemens Atellica CH Urine Albumin In Vitro Diagnostic Recall
FDA (Devices) · 2026-08-12
- ModerateSiemens Tricyclic Antidepressant Calibrator/Controls Recall Lot U2
FDA (Devices) · 2026-08-12
- LowSyva Emit Disopyramide Enzyme Immunoassay Calibrator Recalled for Sodium Azide Concentration
FDA (Devices) · 2026-08-12
Same hazard · mis labeling
See all →- ModerateMedline Trach Tube Kit Recalled for Component Labeling Discrepancy
FDA (Devices) · 2026-09-02
- ModerateAVID Medical Recalls Halyard Total Joint Kits for Latex Labeling Deficiency
FDA (Devices) · 2026-09-02
- ModerateOlympus Recalls PowerSeal Sealer Due to Incorrect Outer Box Labeling
FDA (Devices) · 2026-09-02
- HighSura Tanmen Ramen Noodles Recalled for Undeclared Fish Allergens
FDA (Food) · 2026-09-02
- SevereWhite Vein Advanced Alkaloids Chewable Tablets Recall for Excess Active Ingredient
FDA (Food) · 2026-09-02