Z-1400-2013Class II

Synchron LX System(s) and UniCel DxC 600/800 System(s) Lactate Reagent, Part Number: A95550

Name: Z-1400-2013 Synchron LX System(s) and UniCel DxC 600/800 System(s) Lactate Reagent, Part Number: A95550
Creator: Beckman Coulter Inc.
Published: 2013-04-17
License: https://open.fda.gov/license/

Siemens Healthcare Diagnostics Inc. / initiated 2013-04-17 / Terminated

FDA source

Beckman Coulter Inc. began a recall of Synchron LX System(s) and UniCel DxC 600/800 System(s) Lactate Reagent, Part Number: A95550 Product Usage: Lactate (LACT) reagent, when used in conjunction... on 2013-04-17. FDA classified it as Class II and gives the reason as "Beckman Coulter initiated the recall for the Lactate Assay (LACT) Lot M206209 as they received a customer complaint of error message (RXN RATE HI), i.e. no numerical values reported for samples containing Lactate...". As of 2026-09-10, the recall status on record is Terminated.

Recall record

Recall number: Z-1400-2013
Classification: Class II
Status: Terminated
Initiated: 2013-04-17
Posted: 2013-05-24
Terminated: 2014-10-22
Recalling firm: Siemens Healthcare Diagnostics Inc.
Product: Synchron LX System(s) and UniCel DxC 600/800 System(s) Lactate Reagent, Part Number: A95550 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 initiated the recall for the Lactate Assay (LACT) Lot M206209 as they received a customer complaint of error message (RXN RATE HI), i.e. no numerical values reported for samples containing Lactate concentration greater than 6.5 mmol/L.
FDA root cause: Under Investigation by firm
Action: Beckman Coulter sent an Urgent Product Correction letter dated April 17, 2013 to all affected customers. The letter identified the affected product, problem actions to be taken. Customers are instructed to complete and return the enclosed Response Form within 10 days. Customers with questions are instructed to contact Beckman Coulter Customer Support Center (Call Center) on the Beckman Website at http://www.beckmancoulter.com/customersupport/support/ or call (800) 854-3633 in the US and Canada.
Quantity in commerce: 8,774 units
Distribution: Worldwide Distribution - USA Nationwide and the countries of Canada, Australia, Belgium, Czech Republic, France, French Polynesia, Germany, Greece, Hong Kong, Ireland, Italy, Japan, Jordon, Kuwait, Lebanon, Malawi, Morocco, Namibia, Netherlands, oman, Panama, Paraguay, Qatar, Reunion, Singapore, Slovakia, South Africa, Spain, Sweden, Switzerland, Taiwan, Thailand, Tunisia, Turkey, United Arab Emirates, United Kingdom
Product codes and lots: Lot Number: M206209

Enforcement reports

One row per recalled product line

FDA enforcement reports joined to recall event Z-1400-2013
Recall number	Class	Status	Voluntary or mandated	Report date	Classified
Z-1400-2013	Class II	Terminated	Voluntary: Firm initiated	2013-06-05	2013-05-24

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)