FDA Device recall Z-0110-2013
Synchron Systems Synchron Calibrator Multi Calibrator Diskettes, Part Number 442600
- FDA Device
- Class III
- terminated
- Published 2012-10-31
On 2012-10-31 the FDA classified a Class III recall of Synchron Systems Synchron Calibrator Multi Calibrator Diskettes, Part Number 442600 by Beckman Coulter, citing 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 Thy….
Read the official FDA Device notice
| Agency | FDA Device |
|---|---|
| Recall number | Z-0110-2013 |
| Classification | Class III |
| Status | terminated |
| Initiated | 2011-12-15 |
| Published | 2012-10-31 |
| Last updated | 2026-09-13 11:53 UTC |
| Company | Beckman Coulter |
| Distribution | US |
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.
Reason
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.
Identifiers
| code_info | Lot M002642 |
|---|
Status history
No status changes recorded since RecallRadar first saw this recall on 2026-09-13 11:53 UTC. Current status: terminated.
Source
Official record: https://api.fda.gov/device/enforcement.json?search=recall_number:%22Z-0110-2013%22
RecallRadar indexes public recall notices from the FDA, USDA FSIS, and CPSC. The official agency notice is the authoritative source. Always confirm details at the linked source before acting.