Z-2730-2017Class II

Beckman Coulter Synchron AQUA CAL Level 1, Part No. 471288

Name: Z-2730-2017 Beckman Coulter Synchron AQUA CAL Level 1, Part No. 471288
Creator: Beckman Coulter Inc
Published: 2017-05-15
License: https://open.fda.gov/license/

Siemens Healthcare Diagnostics Inc. / initiated 2017-05-15 / Terminated / root cause: manufacturing process

FDA source

Beckman Coulter Inc began a recall of Beckman Coulter Synchron AQUA CAL Level 1, Part No. 471288 Product Usage: Used for the system calibration of Na, K, Cl, Urea N, Urea, Glucose Creatine, Ca... on 2017-05-15. FDA classified it as Class II and gives the reason as "The firm identified a negative shift of 5mmol/L for sodium recovery in Synchron Control Level 3 when calibrated with AQUA Cal 1". 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-2730-2017
Classification: Class II
Status: Terminated
Initiated: 2017-05-15
Posted: 2017-07-13
Terminated: 2020-09-09
Recalling firm: Siemens Healthcare Diagnostics Inc.
Product: Beckman Coulter Synchron AQUA CAL Level 1, Part No. 471288 Product Usage: Used for the system calibration of Na, K, Cl, Urea N, Urea, Glucose Creatine, Ca, CO2, and P in UniCel DxC Systems.
Product code: JIX Calibrator, Multi-Analyte Mixture
Reason for recall: The firm identified a negative shift of 5mmol/L for sodium recovery in Synchron Control Level 3 when calibrated with AQUA Cal 1.
Root cause tag: manufacturing process
FDA root cause: Nonconforming Material/Component
Action: Recall notices will be sent via mail or email to customers the week of 05/15/2017. Customers are instructed to discard the affected calibrator and request a replacement. Call Client Services at (800) 526-3821 (US only)
Quantity in commerce: 4444 AQUA CAL Level 1 kits
Distribution: US Nationwide Distribution in the states of AL, AR, AK, CA, CO, DE, FL, GA, ID, IL, IN, IO, KS, KY, LA, MA, MD, MS, MI, ME, MO, NE, NV, NJ, NM, NY, NC, ND, OH, OK, OR, PA, RI, SC, TN, TX, VA, WA, WV, WI, and Puerto Rico Brunei, Canada, China, Czech Republic, France, Guatemala, Hong Kong, India, Ireland, Italy, Japan, Lebanon, Mexico, Netherlands, Panama, Paraguay, Philippines, Qatar, South Africa, Taiwan, Thailand, Turkey, United Arab Emirates, & United Kingdom.
Product codes and lots: Lot No. 72645074, Exp. Date 30 Apr 2018

Enforcement reports

One row per recalled product line

FDA enforcement reports joined to recall event Z-2730-2017
Recall number	Class	Status	Voluntary or mandated	Report date	Classified
Z-2730-2017	Class II	Terminated	Voluntary: Firm initiated	2017-07-19	2017-07-13

Product code JIX

K071277Class IISynchron Lx20 Clinical Systems, Creatinine Test SystemsBeckman Coulter, Inc. / cleared 2007-06-01

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)