MicroScan Synergies Plus Negative Panels, 20 panels per box recallZ-0541-2009 · Siemens Microscan · initiated Jul 31, 2008
Terminated All recalls posted in February 2009
Is my device affected?
- Compare the model, catalog and lot or serial numbers on your device or its packaging with the code information below. A recall usually covers only specific models or lots.
- If yours is listed, follow the instructions from Siemens Microscan or your healthcare provider. The company's action is summarized under what the company is doing.
- Do not stop using a prescribed or implanted device on your own — talk to your healthcare provider first.
Where to find your model and lot numbers · What recall classes and statuses mean
Why it was recalled
Falsely lowered imipenem MICs may result, leading to major errors in results.
FDA root cause category: Other
What the company is doing
Consignees were notified on July 31, 2008 by letter (Urgent Device Correction) sent via FedEx overnight. International consignees were notified by Siemens Healthcare Diagnostics associates in affected countries. The letter described the problem and provided users with safety instructions to follow until an update is provided. Contact Siemens Healthcare Diagnostics Inc. at 916-374-3075 for additional assistance.
Recall details
- Recall number
- Z-0541-2009
- Recall class
- Not yet classified by the FDA
- Status
- Terminated
- Initiated by the company
- Jul 31, 2008
- Posted by the FDA
- Feb 4, 2009
- Recalling firm
- Siemens Microscan
- Quantity
- Total of both Negative and Synergy: 569,375 boxes
- Product code
- JWY
- FDA submissions
- K870074
- Distribution
- Worldwide
Product description
MicroScan Synergies Plus Negative Panels, 20 panels per box Medical device designed for use in determining quantitative and/or qualitative antimicrobial agent susceptibility and/or identification to the species level of colonies, grown on solid media, of rapidly growing aerobic and facultative anaerobic gram-negative bacteria. Catalog Nos. B1016-200, B1016-201, B1016-202, B1016-203, B1025-103, B1025-104, B1025-105, B1025-106, B1025-107, B1025-108, B1025-109, B1025-112, and B1027-101
Code information (models, lots, serial numbers)
All lots
Other devices under the same FDA submission
1 device cleared under K870074 — the recall does not name any of them by identifier. One submission often covers many models, so they may or may not be affected.
- MicroScan B1017-216Beckman Coulter, Inc. · Susceptibility Test Cards, Antimicrobial1 recall0 reports
Sources and updates
- Recall record: FDA Medical Device Recalls, file dated Oct 16, 2026 · View the FDA recall notice ↗
- Devices: FDA GUDID, file dated Oct 13, 2026. Devices are linked when their identifier (with a valid check digit) appears in the recall's code information.
- Page last rebuilt: Oct 18, 2026. Text above is shown as published by the FDA.
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