Recall Z-2195-2010
Beckman Coulter Inc. · initiated May 21, 2010
Product
IMMAGE Immunochemistry Systems Buffer 1 (BUF1), Part Number: 447650
Codes / lots: Lot#s: T908069, T908104, T909110, T001036 ( This lot was not shipped to customers.)
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.
FDA-determined cause: Nonconforming Material/Component
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.
Details
- Recall number
- Z-2195-2010
- Initiated
- May 21, 2010
- Posted by FDA
- August 10, 2010
- Terminated
- May 22, 2012
- Product code
- JQX – Nephelometer, For Clinical Use
- 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, Spain, Sweden, Switzerland, Taiwan, Tunisia, Turkey and United Kingdom,
- Recalling firm
- Beckman Coulter Inc., Brea, CA