Z-2195-2010

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

Name: Z-2195-2010 IMMAGE Immunochemistry Systems Buffer 1 (BUF1), Part Number: 447650
Creator: Beckman Coulter Inc.
Published: 2010-05-21
License: https://open.fda.gov/license/

Siemens Healthcare Diagnostics Inc. / initiated 2010-05-21 / Terminated / root cause: manufacturing process

FDA source

Beckman Coulter Inc. began a recall of IMMAGE Immunochemistry Systems Buffer 1 (BUF1), Part Number: 447650 on 2010-05-21. The reason FDA records is "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...". As of 2026-09-10, the recall status on record is Terminated, and MDM tags the root cause as manufacturing process.

Recall record

Recall number: Z-2195-2010
Status: Terminated
Initiated: 2010-05-21
Posted: 2010-08-10
Terminated: 2012-05-22
Recalling firm: Siemens Healthcare Diagnostics Inc.
Product: IMMAGE Immunochemistry Systems Buffer 1 (BUF1), Part Number: 447650
Product code: JQX Nephelometer, For Clinical Use
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.
Root cause tag: manufacturing process
FDA 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 in commerce: 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,
Product codes and lots: Lot#s: T908069, T908104, T909110, T001036 ( This lot was not shipped to customers.)

Product code JQX

K962294Class IImmage Immunochemistry SystemBeckman Instruments, Inc. / cleared 1996-08-21

MDM coverage of this record lists here, newest first.

About this record

Sourced from the FDA device recall database and the FDA enforcement reports, both ingested from openFDA. The recall record supplies the product, the reason and the product code; the enforcement report supplies the classification. The two datasets are exported by FDA on different days, and the date above is the older of the two, so nothing on this page is newer than it says.

MDM adds the root cause tag, derived from FDA’s own root cause text, and the cross-links to the product code, the clearances named on the record and MDM coverage. Where a recall has not been joined to an enforcement report, no classification is shown.

Data as of 2026-09-30, the FDA export date for this dataset. Page last changed 2026-09-05. View this recall on fda.gov (opens on fda.gov)