FDA Medical Device Recalls (openFDA)
Becton Dickinson & Co.: BD GeneOhm Cdiff Assay, Catalog 441401, 200 tests/kit, labeled, in part ***BD Diagnostics, 2555 Boul. Du Parc-Technologique, Quebec, Canada G1P4S5*** Intended for use as an aid in diagnosis of CDAD.
- Recall number
- Z-2174-2010
- Recalling firm
- Becton Dickinson & Co.
- Product
- BD GeneOhm Cdiff Assay, Catalog 441401, 200 tests/kit, labeled, in part ***BD Diagnostics, 2555 Boul. Du Parc-Technologique, Quebec, Canada G1P4S5*** Intended for use as an aid in diagnosis of CDAD.
- Status
- Terminated
- Initiated
- 2010-03-05
- Posted
- 2010-08-05
- Terminated
- 2010-10-15
- Reason
- In vitro diagnostic test kits do not perform to specifications.
- Root cause
- Nonconforming Material/Component
- Action
- The recalling firm notified accounts by an Urgent Product Recall letter on 03/05/2020. The letter identified the affected product and explained the reason for recall. It also advised customers to discontinue use of the affected product and discard any remaining inventory and fax back an acknowledgement form. The letter stated that BD will provide replacements for any discarded product. Further assistance can be obtained by contacting BD Technical Service at 1-888-436-3646.
- Quantity
- 31 kits
- Distribution
- Nationwide Distribution -- IL, IN, PA, WA, CA, VA, NJ, and KS.
- Lot, serial or model codes
- Lot/Exp date: 08T09101 2010-06-30 08T09101A 2010-06-30 08T09103 2010-07-02
- 510(k) numbers
- ["K081920"]
- PMA numbers
- not on file
- Product code
- LLH
- Firm FEI
- 1119779
- Firm city
- Sparks
- Firm state
- MD
- 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