FDA Medical Device Recalls (openFDA)
Siemens Healthcare Diagnostics, Inc.: 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.
- Recall number
- Z-1499-2012
- Recalling firm
- Siemens Healthcare Diagnostics, Inc.
- Product
- 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.
- Status
- Terminated
- Initiated
- 2011-06-16
- Posted
- 2012-05-08
- Terminated
- 2012-05-08
- Reason
- 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
- Root cause
- Process control
- Action
- 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.
- Quantity
- 683 boxes (20 panels per box)
- Distribution
- Worldwide Distribution -- US, Turkey, Poland, and Great Britain.
- Lot, serial or model codes
- lot code 2011-12-15.
- 510(k) numbers
- ["K862140"]
- PMA numbers
- not on file
- Product code
- JWY
- Firm FEI
- 2919016
- Firm city
- West Sacramento
- Firm state
- CA
- Firm country
- not on file
Where this comes from
- Register
- FDA Medical Device Recalls (openFDA)
- Publisher
- U.S. Food and Drug Administration (openFDA)
- File
- device-recall-0001-of-0001.json.zip
- sha256
- b87518bfe2e8
- Size
- 288210821 bytes
- Published
- 2026-09-28
- Read
- 2026-09-29T08:25:23.626Z
- Source file
- Source file retained · verify
- Refresh due
- 2026-10-06
Unless otherwise noted, the content, data, documentation, code, and related materials on openFDA is public domain and made available with a Creative Commons CC0 1.0 Universal dedication.
Cite as
FDA Medical Device Recalls (openFDA) (U.S. Food and Drug Administration (openFDA)), device-recall-0001-of-0001.json.zip, sha256 b87518bfe2e8, published 2026-09-28