Recall Z-2045-2011 ยท LDT
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 quant
| Date | Apr 20, 2011 (initiated Aug 24, 2010) |
| Status | Terminated |
| 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 wa |
| Quantity | 9 units total in US |
| Distribution | Nationwide distribution: USA including states of : AL, CA, MI and IN. |
| FDA record | Open on fda.gov |
510(k) clearances named in this recall
| K962294 | IMMAGE IMMUNOCHEMISTRY SYSTEM Beckman Instruments, Inc., Aug 21, 1996 |