Z-1613-2013Class II

SYNCHRON System(s) Lactate (LACT) Reagent

Name: Z-1613-2013 SYNCHRON System(s) Lactate (LACT) Reagent
Creator: Beckman Coulter Inc.
Published: 2013-05-28
License: https://open.fda.gov/license/

Siemens Healthcare Diagnostics Inc. / initiated 2013-05-28 / Terminated / root cause: manufacturing process

FDA source

Beckman Coulter Inc. began a recall of SYNCHRON System(s) Lactate (LACT) Reagent. Product Usage: Lactate (LACT) reagent, when used in conjunction with Synchron LX System(s), UniCel DxC 600/800... on 2013-05-28. FDA classified it as Class II and gives the reason as "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...". As of 2026-09-10, the recall status on record is Terminated, and MDM tags the root cause as manufacturing process.

Recall record

Recall number: Z-1613-2013
Classification: Class II
Status: Terminated
Initiated: 2013-05-28
Posted: 2013-06-27
Terminated: 2014-06-03
Recalling firm: Siemens Healthcare Diagnostics Inc.
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).
Product code: KHP Acid, Lactic, Enzymatic Method
Reason for recall: 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.
Root cause tag: manufacturing process
FDA root cause: Under Investigation by firm
Action: Beckman Coulter Inc. sent an Urgent Product Correction letter dated May 28, 2013 to affected customers. The letter identified the affected product, the issue, impact, actions to be taken, and resolution. The letter instructed customers to discontinue use of the affected product and request a replacement product. For questions contact Customer Support Center (Call Center) on the Beckman Coulter website at http://www.beckmancoulter.com/customersupport/support/ or call 800-854-3633 in the United States and Canada. Outside the United States or Canada, contact your local Beckman Coulter Representative.
Quantity in commerce: 3,353 units
Distribution: Worldwide Distribution - USA Nationwide and country of Canada.
Product codes and lots: Part Number A95550, Lot Number M210077

Enforcement reports

One row per recalled product line

FDA enforcement reports joined to recall event Z-1613-2013
Recall number	Class	Status	Voluntary or mandated	Report date	Classified
Z-1613-2013	Class II	Terminated	Voluntary: Firm initiated	2013-07-03	2013-06-27

Product code KHP

The FDA recall record names no cleared device, and no clearance has been matched to it.

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 2026-10-14, the FDA export date for this dataset. Page last changed 2026-09-05. View this recall on fda.gov (opens on fda.gov)