IMMAGE Immunochemistry Systems Wash Solution Part Number: 447060 The IMMAGE Immunochemistry Systems Wash Solution is int
FDA device recall Z-2045-2011 · posted 2011-04-20 · Terminated
Recall details
- Recalling firm
- Beckman Coulter Inc.
- Reason for recall
- 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.
- Action taken
- 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.
- Root cause
- Other
- Status
- Terminated
- Product code
- LDT
- Quantity affected
- 9 units total in US
- Distribution
- Nationwide distribution: USA including states of : AL, CA, MI and IN.
- Date initiated
- 2010-08-24
- Date posted
- 2011-04-20
- Date terminated
- 2012-06-26
- Location
- Brea, CA
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Related 510(k) clearances
| Record | Firm | Date |
|---|---|---|
| IMMAGE IMMUNOCHEMISTRY SYSTEM (K962294) | Beckman Instruments, Inc. | 1996-08-21 |