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Terminated

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

FDA Recall Z-2195-2010 · Posted 2010-08-10

Recalling FirmBeckman Coulter Inc.
Recall StatusTerminated
Product CodeJQX
Date Initiated2010-05-21
Date Terminated2012-05-22
Product Quantity1309

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.

Firm 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.

Root Cause

Nonconforming Material/Component

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,

Related FDA 510(k) Records

Devices referenced by this recall via K-numbers.

K962294IMMAGE IMMUNOCHEMISTRY SYSTEMBeckman Instruments, Inc. · 1996-08-21

Official Source

View FDA Recall →

Source: FDA Enforcement Report / Recall database. Always confirm against the official FDA record.

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