—#91778

Product

IMMAGE Immunochemistry Systems Buffer 1 (BUF1), Part Number: 447650

FDA product code: JQX — Nephelometer, For Clinical Use
Device class: Class 1
Medical specialty: Clinical Chemistry
510(k) numbers: K962294
Affected lot / code info: Lot#s: T908069, T908104, T909110, T001036 ( This lot was not shipped to customers.)

Why it was recalled

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 (FDA determination)

Nonconforming Material/Component

Action the firm took

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.

Recalling firm

Firm: Beckman Coulter Inc.
Address: 200 S Kraemer Blvd, Brea, California 92821-6208

Distribution

Distribution pattern: 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,

Timeline

Recall initiated: 2010-05-21
Posted by FDA: 2010-08-10
Terminated: 2012-05-22
Status: —

Source: openFDA Device Recall endpoint. Recall record ID #91778. The FDA issues recall classifications as health-hazard assessments, not legal findings; for legal claims consult a licensed attorney.