Z-2226-2011

SYNCHRON Systems Calibrator 1, Part Numbers: 468405, Lots prior to M005558 The Beckman Coulter SYNCHRON...

Name: Z-2226-2011 SYNCHRON Systems Calibrator 1, Part Numbers: 468405, Lots prior to M005558 The Beckman Coulter SYNCHRON...
Creator: Beckman Coulter Inc.
Published: 2011-03-11
License: https://open.fda.gov/license/

Siemens Healthcare Diagnostics Inc. / initiated 2011-03-11 / Terminated / root cause: manufacturing process

FDA source

Beckman Coulter Inc. began a recall of SYNCHRON Systems Calibrator 1, Part Numbers: 468405, Lots prior to M005558 The Beckman Coulter SYNCHRON Calibrator 1 (CAL 1), used in conjunction with SYNCHRON... on 2011-03-11. The reason FDA records is "The recall was initiated because standardization of the Synchron Systems Calibrator 1, used for both the Synchron LX and UniCel DxC systems, has been established to the new IFCC Reference Preparation for Plasma...". 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-2226-2011
Status: Terminated
Initiated: 2011-03-11
Posted: 2011-05-20
Terminated: 2012-05-04
Recalling firm: Siemens Healthcare Diagnostics Inc.
Product: SYNCHRON Systems Calibrator 1, Part Numbers: 468405, Lots prior to M005558 The Beckman Coulter SYNCHRON Calibrator 1 (CAL 1), used in conjunction with SYNCHRON reagents, is intended for the calibration of immunoprotein tests on SYNCHRON LX and UniCel DxC Systems.
Product code: JIT Calibrator, Secondary
Reason for recall: The recall was initiated because standardization of the Synchron Systems Calibrator 1, used for both the Synchron LX and UniCel DxC systems, has been established to the new IFCC Reference Preparation for Plasma Proteins, ERM-DA470k (formerly CR470) beginning with lot number M005558. During the standardization to the new IFCC standard, ERM-DA470k, we confirmed that Complement C4 (C4) had been re
Root cause tag: manufacturing process
FDA root cause: Pending
Action: Beckman Coulter initiated a Product Corrective Action (PCA) letter on the week of March 14, 2011, to the affected customers. Though Beckman is recalling the LX Cal 1, the recall letter was sent to the C4 reagent customers, as these are the only customers who will be impacted by the problem noted in the PCA letter. The letter provided the customers with an explanation of the problem identified and an action to be taken. The letter recommended consignees take the following actions: (1)Notify their clients to review and evaluate the impact on patients whose Complement C4 recovered near the clinical decision points. (2) Re-evaluate their laboratory's reference ranges for C4. The letter further requested that consignees share this information with laboratory staff and retain this notification as part of your laboratory Quality System documentation. Questions regarding this Product Announcement letter, or requests for the correlation graphs should be directed to Customer Support Center (Call Center) on the Beckman Coulter website at www.BeckmanCoulter.com/Customer Support/Support Request or call (800) 854-3633 in the United States and Canada.
Quantity in commerce: 96,173 units
Distribution: Worldwide Distribution - USA (nationwide) and the countries of Argentina, Australia, Belgium, Brunei Darussalam, Bulgaria, Canada, China, Colombia, Costa Rica, Czech Republic, Denmark, Eritrea, France, French Polynesia, Germany, Greece, Hong Kong, India, Ireland, Israel, Italy, Japan, Korea, Republic of Kuwait, Lebanon, Lithuania, Malaysia, Mexico, Namibia, Netherlands, New Caledonia, New Zealand, Oman, Panama, Poland, Puerto Rico, Qatar Reunion, Russian Federation, Rwanda, Serbia, Singapore, Slovakia, South Africa, Spain, Swaziland, Sweden, Switzerland, Taiwan, Thailand, Tunisia, Turkey, United Arab Emirates, United Kingdom, and Viet Nam
Product codes and lots: Lots prior to M005558

Product code JIT

K965108Class IISynchron Lx Systems Immunoglobulin G/a/m ReagentBeckman Instruments, Inc. / cleared 1997-03-06

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 2026-10-07, the FDA export date for this dataset. Page last changed 2026-09-05. View this recall on fda.gov (opens on fda.gov)