Z-0110-2013Class III

Synchron Systems Synchron Calibrator Multi Calibrator Diskettes, Part Number 442600. The SYNCHRON...

Name: Z-0110-2013 Synchron Systems Synchron Calibrator Multi Calibrator Diskettes, Part Number 442600. The SYNCHRON...
Creator: Beckman Coulter Inc.
Published: 2011-12-15
License: https://open.fda.gov/license/

Siemens Healthcare Diagnostics Inc. / initiated 2011-12-15 / Terminated / root cause: labeling and UDI

FDA source

Beckman Coulter Inc. began a recall of Synchron Systems Synchron Calibrator Multi Calibrator Diskettes, Part Number 442600. The SYNCHRON MULTI-CALIBRATOR, used in conjunction with SYNCHRON reagents... on 2011-12-15. FDA classified it as Class III and gives the reason as "The recall was initiated because Beckman Coulter has confirmed a mislabeling error, some Synchron Systems Multi Calibrator Diskettes (REF 442600, lot M002642G) may actually be Thyroxine (T4) Reagent Calibrator Diskettes". As of 2026-09-10, the recall status on record is Terminated, and MDM tags the root cause as labeling and UDI.

Recall record

Recall number: Z-0110-2013
Classification: Class III
Status: Terminated
Initiated: 2011-12-15
Posted: 2012-10-22
Terminated: 2012-12-28
Recalling firm: Siemens Healthcare Diagnostics Inc.
Product: Synchron Systems Synchron Calibrator Multi Calibrator Diskettes, Part Number 442600. The SYNCHRON MULTI-CALIBRATOR, used in conjunction with SYNCHRON reagents, is intended for use on SYNCHRON Systems for the calibration of Albumin, Blood Urea Nitrogen (Urea), Calcium, Cholesterol, Glucose, Inorganic Phosphorus, Lactate,Magnesium, Total Protein, Triglycerides, and Uric Acid.
Product code: JIX Calibrator, Multi-Analyte Mixture
Reason for recall: The recall was initiated because Beckman Coulter has confirmed a mislabeling error, some Synchron Systems Multi Calibrator Diskettes (REF 442600, lot M002642G) may actually be Thyroxine (T4) Reagent Calibrator Diskettes.
Root cause tag: labeling and UDI
FDA root cause: Labeling mix-ups
Action: Beckman Coulter sent an Urgent Product Correction letter dated December 15, 2011, withan attached Fax Back Response Form to all affected customers. The letter identified the product, the problem, and the action to be taken by the customer. If customers are currently using Multi Calibrator lot M002642, then they were instructed to verified diskette and discard all Multi Calibrator diskettes lot M002642 and M002642G without a dark green dot. Customers were instructed to complete and return the enclosed Response Form within 10 days. Customers were instructed to contact Beckman Coulter Support Center at http:www.beckmancoulter.com/customersupport/support/ or call (800) 854-3633 in the US and Canada. Outside of the US or Canada, customers were instructed to contact their local Beckman Coulter Representatives. For questions regarding this recall call 714-961-4483.
Quantity in commerce: 5746 units total (2729 units in US)
Distribution: Worldwide distribution: USA (Nationwide) and Internationally to: Afghanistan Angola Australia Bangladesh Belgium Bhutan Brazil Brunei Darussalam Bulgaria Canada China Colombia Costa Rica Cote d'Ivoire Czech Republic Denmark Ecuador Egypt El Salvador Eritrea Ethiopia Finland France French Polynesia Germany Ghana Greece Guatemala Hong Kong India Indonesia Ireland Israel Italy Japan Jordan Kenya Kuwait Lebanon Lesotho Libyan Arab Jamahiriya Lithuania Macao Malawi Malaysia Mexico Morocco Namibia Netherlands New Zealand Nigeria Oman Pakistan Panama Paraguay Philippines Poland Puerto Rico Qatar Reunion Romania Russian Federation Rwanda Saudi Arabia Serbia Singapore Slovakia South Africa Spain Swaziland Sweden Switzerland Taiwan Thailand Tunisia Turkey Uganda United Arab Emirates United Kingdom Viet Nam Zambia Zimbabwe
Product codes and lots: Lot M002642

Enforcement reports

One row per recalled product line

FDA enforcement reports joined to recall event Z-0110-2013
Recall number	Class	Status	Voluntary or mandated	Report date	Classified
Z-0110-2013	Class III	Terminated	Voluntary: Firm initiated	2012-10-31	2012-10-22

Product code JIX

K110251Class IISynchron Multi CalibratorBeckman Coulter, Inc. / cleared 2011-05-25

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)