Recall Z-2226-2011 ยท JIT Calibrator, Secondary
Beckman Coulter Inc.
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.
| Date | May 20, 2011 (initiated Mar 11, 2011) |
| Status | Terminated |
| Reason | 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 | 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 clin |
| Quantity | 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, Republi |
| FDA record | Open on fda.gov |
510(k) clearances named in this recall
| K965108 | SYNCHRON LX SYSTEMS IMMUNOGLOBULIN G/A/M REAGENT Beckman Instruments, Inc., Mar 6, 1997 |