Recall Z-2195-2010 ยท JQX Nephelometer, For Clinical Use
Beckman Coulter Inc.
IMMAGE Immunochemistry Systems Buffer 1 (BUF1), Part Number: 447650
| Date | Aug 10, 2010 (initiated May 21, 2010) |
| Status | Terminated |
| Reason | 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. |
| Root cause | Nonconforming Material/Component |
| Action | 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. |
| Quantity | 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, New Zealand, Norway, Oman, Poland, Qatar, Russian Federation, Singapore, Slovakia, South Africa, Spa |
| FDA record | Open on fda.gov |
510(k) clearances named in this recall
| K962294 | IMMAGE IMMUNOCHEMISTRY SYSTEM Beckman Instruments, Inc., Aug 21, 1996 |