FDA Medical Device Recalls (openFDA)
Dade Behring, Inc.: Dade Behring brand MicroScan Prompt Inoculation System-D; Catalog # B1026-10D;
- Recall number
- Z-0247-2007
- Recalling firm
- Dade Behring, Inc.
- Product
- Dade Behring brand MicroScan Prompt Inoculation System-D; Catalog # B1026-10D;
- Status
- Terminated
- Initiated
- 2006-09-27
- Posted
- 2006-12-05
- Terminated
- 2006-12-28
- Reason
- Product does not meet performance specifications through its standardized inocula for MicroScan Dried Gram-Negative and Gram-Positive Overnight panel testing.
- Root cause
- Other
- Action
- On 9/27/06, the firm initiated the recall and its notification was via phone calls and letters (FedEx''ed) explaining the reason for the recall and requesting the product be discarded.
- Quantity
- 828 units
- Distribution
- Worldwide, including USA, China, and Germany.
- Lot, serial or model codes
- Lot Numbers: 20071127, 20071128
- 510(k) numbers
- ["K820299"]
- PMA numbers
- not on file
- Product code
- LIE
- 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