Beckman Coulter Inc.: Medical Device Recall in 2012 - (Recall #: Z-0110-2013)

Updated on March 25, 2026.

See the recall detail below. You can also see other recalls from the same firm in 2012.

Data Source: FDA.

Product Description:

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 Classification:

Class III

Date Initiated: December 15, 2011

Date Posted: October 31, 2012

Recall Number: Z-0110-2013

Event ID: 63130

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.

Status: Terminated

Product Quantity: 5746 units total (2729 units in US)

Code Information:

Lot M002642

Distribution Pattern:

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

Voluntary or Mandated:

Voluntary: Firm initiated