FDA Medical Device Recalls (openFDA)
Becton Dickinson & Company: BD Unopette -- System Tests (Erythrocyte Fragility Test Kit). Catalog # 365830, Exp Date 2006-06, Manufactured by BD in San Lorenzo, Puerto Rico.
- Recall number
- Z-1446-06
- Recalling firm
- Becton Dickinson & Company
- Product
- BD Unopette -- System Tests (Erythrocyte Fragility Test Kit). Catalog # 365830, Exp Date 2006-06, Manufactured by BD in San Lorenzo, Puerto Rico.
- Status
- Terminated
- Initiated
- 2005-06-01
- Posted
- 2006-08-26
- Terminated
- 2006-08-25
- Reason
- Formulation problems-lower pH of the solutions may increase Red Blood Cell hemolysis
- Root cause
- Other
- Action
- Recall letters were sent via first class mail on 7/11/2005 by US mail, return receipt requested. A second notification was sent 8/4/2005
- Quantity
- Lot # 5014328 - 1,980 kits; Lot 5159075 - 4,360 kits
- Distribution
- World wide-USA, Canada, Europe, Asia Pacific.
- Lot, serial or model codes
- Catalog #365830 -- Lot numbers: 5014328 -- exp. June 2006; 5159075 -- exp. July 2006.
- 510(k) numbers
- not on file
- PMA numbers
- not on file
- Product code
- GKE
- Firm FEI
- 2243072
- Firm city
- Franklin Lakes
- Firm state
- NJ
- 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