FDA Medical Device Recalls (openFDA)
Becton Dickinson & Co.: BD BACTEC(TM) Lytic 10 Anaerobic/F Medium, catalog 442265, packed in tubes, 50 tubes/case and labeled in part ***Becton Dickinson and Company, Sparks, MD 21152*** BD BACTEC Media are used in a qualitative procedure for the culture and recovery of microorganisms from blood.
- Recall number
- Z-1009-2010
- Recalling firm
- Becton Dickinson & Co.
- Product
- BD BACTEC(TM) Lytic 10 Anaerobic/F Medium, catalog 442265, packed in tubes, 50 tubes/case and labeled in part ***Becton Dickinson and Company, Sparks, MD 21152*** BD BACTEC Media are used in a qualitative procedure for the culture and recovery of microorganisms from blood.
- Status
- Terminated
- Initiated
- 2009-11-11
- Posted
- 2010-03-08
- Terminated
- 2010-05-13
- Reason
- The draw volume on test tubes of blood culture medium is marked with graduations that may be confusing for healthcare practitioners using the tubes for appropriate collection of patient samples for microbiological laboratory testing.
- Root cause
- Component change control
- Action
- An "URGENT CUSTOMER NOTIFICATION" was sent via UPS to customers. The notification letter described the product, problem and action to be taken. The letter alerted customers that the firm had recently manufactured identified lots of BACTEC(tm) Blood Culture Media with a new label containing a red line which should not be used as an accurate indication for blood draw volume. The firm also advised that the manufacturer is working to build stock with a revised label, but all of the identified lots distributed had passed testing and release criteria and will continue to perform as expected when used as instructions indicate. The customers are being urged to pay close attention to their BACTEC blood collection procedure until they receive bottles with the revised labels. Drawing too much blood may contribute to false negative or false positive results. The customer is being ask to communicate this information to all specimen collection sites within their facility. If further assistance is needed, please contact BD Technical Services Department at 1-800-638-8663.
- Quantity
- 1,267,725 bottles
- Distribution
- Worldwide Distribution: USA and Canada, Japan, Australia, Singapore, Korea, Brazil, Taiwan, China, Mexico, Germany, New Zealand, Hong Kong, Uruguay
- Lot, serial or model codes
- 9233292 exp 6/30/2010 9233294 exp 6/30/2010 9257192 exp 6/30/2010 9257221 exp 6/30/2010 9257224 exp 6/30/2010 9267233 exp 7/31/2010 9267236 exp 7/31/2010 9267238 exp 7/31/2010 9267240 exp 7/31/2010 9267242 exp 7/31/2010 9267243 exp 7/31/2010 9267244 exp 7/31/2010 9267245 exp 7/31/2010 9267246 exp 7/31/2010 9267249 exp 7/31/2010
- 510(k) numbers
- ["K921133"]
- PMA numbers
- not on file
- Product code
- MDB
- 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