IMMAGE Immunochemistry Systems Buffer 1 (BUF1), Part Number: 447650
FDA device recall Z-2195-2010 · posted 2010-08-10 · Terminated
Recall details
- Recalling firm
- Beckman Coulter Inc.
- Reason for recall
- Beckman Coulter is initiating a recall of IMMAGE Immunochemistry Systems Buffer 1 (BUF1) due to received reports of increased recovery of control and patient samples using the lots of IMMAGE BUF1. Some lots of BUF1 have been reported to cause high shifts in recovery of control or patient samples. Quality Control failures may result after replacing BUF1 with a different lot.
- Action taken
- Beckman Coulter will send a Product Corrective Action (PCA) letter on the week of April 19, 2010 to the affected customers. The letter provided the customers with an explanation of the problem and a work around.
- Root cause
- Nonconforming Material/Component
- Status
- Terminated
- Product code
- JQX
- Quantity affected
- 1309
- Distribution
- Worldwide: U.S., Canada, Australia, Austria, Belgium, China, Czech Republic, Denmark, France, Germany, Greece, Hong Kong, Iceland, Ireland, Italy, Japan, Liechtenstein, Macao, Malaysia, Netherlands, N
- Date initiated
- 2010-05-21
- Date posted
- 2010-08-10
- Date terminated
- 2012-05-22
- Location
- Brea, CA
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Related 510(k) clearances
| Record | Firm | Date |
|---|---|---|
| IMMAGE IMMUNOCHEMISTRY SYSTEM (K962294) | Beckman Instruments, Inc. | 1996-08-21 |