Class II — Beckman Coulter Inc.
| Recalling firm | BECKMAN COULTER, INC. |
|---|---|
| Registered facility | View this company's 22 registered facilities → (openFDA recall records do not name a specific facility) |
| Classification | Class II |
| Status | Terminated |
| Reason | Beckman Coulter has confirmed customer reports of LACT Lot M210077 failing calibration with error condition OCR LOW. The calibration failures appear to be related to improper shipping or storage conditions (frozen reagent). Failed calibration of LACT may cause a delay in reporting results. |
| Product | SYNCHRON System(s) Lactate (LACT) Reagent. Product Usage: Lactate (LACT) reagent, when used in conjunction with Synchron LX® System(s), UniCel® DxC 600/800 System(s) and Synchron® Systems Multi Calibrator, is intended for the quantitative determination of lactate concentration in human plasma and cerebrospinal fluid (CSF). |
| Quantity | 3,353 units |
| Distribution | Worldwide Distribution - USA Nationwide and country of Canada. |
| Initiated | 2013-05-28 |
| Classified | 2013-06-27 |
| Terminated | 2014-06-03 |
| Recall number | Z-1613-2013 |
| Initiation | Voluntary: Firm initiated |
Source: U.S. FDA via openFDA (opens in a new tab) (device registration & enforcement). Data as of 2026-10-06. Verify this recall record at FDA → (opens in a new tab)
Cite this record
RegWarden. “Class II recall — Beckman Coulter Inc. (Z-1613-2013).” Compiled from U.S. FDA public records (openFDA; FDA Data Dashboard). Data as of 2026-10-06. https://regwarden.com/recall/65377/
Alerts for BECKMAN COULTER, INC.
Watchlist alerts will email you when FDA publishes a new recall, inspection classification, or warning letter for a facility you follow. They aren't open to the public yet — leave your email and we'll tell you when they are.
Want a one-page facility brief?
A single-page summary of this facility's registration and recall history for diligence. Not selling it yet — register interest and we'll follow up.