FDA Medical Device Recalls (openFDA)
Beckman Coulter Inc.: IMMAGE Immunochemistry Systems Wash Solution Part Number: 447060 The IMMAGE Immunochemistry Systems Wash Solution is intended for use with IMMAGE Immunochemistry Systems and reagents for the quantitative determinations of components in biological fluids. The Beckman Coulter IMMAGE Immunochemistry System is a fully automated, computer controlled, bench-top analyzer designed for the in vitro quantitation of biological fluid components and therapeutic drugs. The system methodologies are rate turbidimetry and rate nephelometry.
- Recall number
- Z-2045-2011
- Recalling firm
- Beckman Coulter Inc.
- Product
- IMMAGE Immunochemistry Systems Wash Solution Part Number: 447060 The IMMAGE Immunochemistry Systems Wash Solution is intended for use with IMMAGE Immunochemistry Systems and reagents for the quantitative determinations of components in biological fluids. The Beckman Coulter IMMAGE Immunochemistry System is a fully automated, computer controlled, bench-top analyzer designed for the in vitro quantitation of biological fluid components and therapeutic drugs. The system methodologies are rate turbidimetry and rate nephelometry.
- Status
- Terminated
- Initiated
- 2010-08-24
- Posted
- 2011-04-20
- Terminated
- 2012-06-26
- Reason
- The recall was initiated because Beckman Coulter has confirmed an Immage Systems Wash Solution Lot 71744 was manufactured by a Beckman European facility and not intended to be used in the U.S. However, this lot was inadvertently shipped to the U.S. and delivered to five customers.
- Root cause
- Other
- Action
- The firm, Beckman Coulter, contacted the customers who received the IMMAGE Immunochemistry Systems Wash Solution, lot #71744 by telephone. Beckman sent a follow-up "URGENT: PRODUCT CORRECTIVE ACTION" letter dated August 25, 2010, to all affected customers. The letter described the product, problem and actions to be taken. The customers were instructed to discontinue use of Immage Immunochemistry Systems Wash Solution lot 71744; return the material to Beckman Coulter's Chino warehouse: Beckman Coulter Inc., 15989 Cypress Ave, Chino, CA 91710, Phone: 909-597-3967; package the material the way it arrived and use Beckmans internal Fedex account to ship the material; complete and return an enclosed FAX BACK RESPONSE FORM within 10 days via fax to (714) 961-4234 or mail to: Beckman Coulter, Inc., Attn: Regulator Affairs, 250 S. Kraemer Blvd, Brea, California 92821, Mail code E2.Se.08; share this information with laboratory staff; retain the notification as part of their Quality System documentation, and provide a copy of the letter if they forwarded the affected products. If you have any questions regarding this letter, please call Beckmans Customer Support Center (Hotline) at (800) 854-3633 in the United States and Canada.
- Quantity
- 9 units total in US
- Distribution
- Nationwide distribution: USA including states of : AL, CA, MI and IN.
- Lot, serial or model codes
- Lot Numbers: 71744
- 510(k) numbers
- ["K962294"]
- PMA numbers
- not on file
- Product code
- LDT
- Firm FEI
- 2050012
- Firm city
- Brea
- 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