MicroScan Dried Overnight Gram Negative Panels recallZ-1499-2012 · Siemens Healthcare Diagnostics, Inc. · initiated Jun 16, 2011
Terminated All recalls posted in May 2012
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 Healthcare Diagnostics, Inc. 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
Three lots were confirmed to not meet performance claims due to random non-biological contamination which is only apparent (precipated) after inoculation of the panels
FDA root cause category: Process control
What the company is doing
Customer Notification letters were sent to all customers of the three MicroScan panels by traceable mail. The letter identified the affected product and asked customers to discard any remaining inventory in addition to contacting customer service for replacement product. The letter also recommended that customers consider the need to review previous test results, conduct patient follow-up, and or repeat tests as needed. Customers were to complete and return the customer reply card to confirm that they received and understood the recall communication.
Recall details
- Recall number
- Z-1499-2012
- Recall class
- Not yet classified by the FDA
- Status
- Terminated
- Initiated by the company
- Jun 16, 2011
- Posted by the FDA
- May 8, 2012
- Recalling firm
- Siemens Healthcare Diagnostics, Inc.
- Quantity
- 683 boxes (20 panels per box)
- Product code
- JWY
- FDA submissions
- K862140
- Distribution
- Worldwide Distribution -- US, Turkey, Poland, and Great Britain.
Product description
MicroScan Dried Overnight Gram Negative Panels; Panel type: Neg Breakpoint Combo Type 47, catalog number: B1017-417. Siemens Healthcare Diagnostics, West Sacramento, CA. 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.
Code information (models, lots, serial numbers)
lot code 2011-12-15.
Other devices under the same FDA submission
1 device cleared under K862140 — 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
Other products in the same recall event
The FDA groups related products into one recall event (event 61610).
- Z-1497-2012 · TerminatedMicroScan Dried Overnight Gram Negative Panels; Panel type: Neg Urine Combo 55; Catalog Number B1017-409. Siemens Healthcare Diagnostics, West Sacramento, CA.
- Z-1498-2012 · TerminatedMicroScan Dried Overnight Gram Negative Panels; Panel type: Neg Breakpoint Combo Type 34, catalog number: B1017-404. Siemens Healthcare Diagnostics, West Sacramento, CA.
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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