FDA Medical Device Recalls (openFDA)
Abbott Laboratories: Abbott brand CELL-DYN Emerald Diluent Reagent, 10 mL, List Number: 09H48-02, Product is manufactured and distributed by Abbott Diagnostics Division, Santa Clara. CA Designed for use on the CELL-DYN Emerald System, which is an automated hematology analyzer designed for in-vitro diagnostic use in clinical laboratories.
- Recall number
- Z-1668-2011
- Recalling firm
- Abbott Laboratories
- Product
- Abbott brand CELL-DYN Emerald Diluent Reagent, 10 mL, List Number: 09H48-02, Product is manufactured and distributed by Abbott Diagnostics Division, Santa Clara. CA Designed for use on the CELL-DYN Emerald System, which is an automated hematology analyzer designed for in-vitro diagnostic use in clinical laboratories.
- Status
- Terminated
- Initiated
- 2010-09-30
- Posted
- 2011-03-17
- Terminated
- 2011-04-07
- Reason
- The product bar code label, when scanned, indicates that the volume is 10 mL rather than the correct volume of 10,000 mL. Analytical results are not impacted, although, there is a potential for delay in generating results.
- Root cause
- Error in labeling
- Action
- Product Recall notification letters were sent on 9/30/2010. The letter identified the affected product, an explanation of the problem, patient impact, and necessary actions. Consignees are to contact their local hematology customer support representative to arrange for replacement of the CELL-DYN Emerald Diluent Lot. Once the replacement lot has been received, customers should destroy the affected lot according to their laboratory procedures. A copy of the letter should be retained for their records and the Customer Reply Form should be completed and returned via fax or e-mail. US customers should contact Customer Support at 1-877-4ABBOTT, if they have questions.
- Quantity
- 322 units
- Distribution
- Worldwide Distribution -- USA, including states of PA, NY, CA, NC, IL, TX, KS, UT, VA, FL, AR, TN, MN, NE, MI, and DE and the country of Germany.
- Lot, serial or model codes
- Lot Number: 4350, Expiration Date: June 30, 2012
- 510(k) numbers
- ["K081495"]
- PMA numbers
- not on file
- Product code
- GKZ
- Firm FEI
- 2919069
- Firm city
- Santa Clara
- 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