FDA Medical Device Recalls (openFDA)
Dade Behring: MicroScan Rapid Pos Inoculum Broth, Catalog #: B1015-14; Manufactured and distributed by: Dade Behring Inc. 2040 Enterprise Blvd. West Sacramento, CA 95691
- Recall number
- Z-0668-05
- Recalling firm
- Dade Behring
- Product
- MicroScan Rapid Pos Inoculum Broth, Catalog #: B1015-14; Manufactured and distributed by: Dade Behring Inc. 2040 Enterprise Blvd. West Sacramento, CA 95691
- Status
- Terminated
- Initiated
- 2005-02-07
- Posted
- 2005-04-06
- Terminated
- 2005-07-05
- Reason
- There is a potential for reporting of false susceptible anti-microbic results that could result in inappropriate and/or less effective therapy.
- Root cause
- Other
- Action
- The customer notifications were sent to U.S. customers on January 27, 2005 via FedEx. International customers are to be notified by Dade Behring affiliates in the affected countries by February 10, 2005. Follow up will be made via phone call.
- Quantity
- 324 boxes
- Distribution
- 71 consignees including customers in U.S., Puerto Rico and distributors. Number of international customers to be determined at completion of effectiveness check.
- Lot, serial or model codes
- Lot Nos.: 050905A-1, 051005A-1, 051605A-1, 051705A-1, 052305A-1, 052805B-1
- 510(k) numbers
- not on file
- PMA numbers
- ["P870049"]
- Product code
- LON
- 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