Z-2389-2010

SYNCHRON Systems Modular Creatinine (CREm) Reagent Kit, Part Number: 472525 Systems AQUA CAL 1 and 2, is...

Name: Z-2389-2010 SYNCHRON Systems Modular Creatinine (CREm) Reagent Kit, Part Number: 472525 Systems AQUA CAL 1 and 2, is...
Creator: Beckman Coulter Inc.
Published: 2010-08-02
License: https://open.fda.gov/license/

Siemens Healthcare Diagnostics Inc. / initiated 2010-08-02 / Terminated

FDA source

Beckman Coulter Inc. began a recall of SYNCHRON Systems Modular Creatinine (CREm) Reagent Kit, Part Number: 472525 Systems AQUA CAL 1 and 2, is intended for the quantitative determination of... on 2010-08-02. The reason FDA records is "The recall was initiated after Beckman Coulter confirmed reports that black / brown particulates were observed in some bottles of the Creatinine Alkaline Buffer (Buffer lot M911427 and M911518) in modular Creatinine...". As of 2026-09-10, the recall status on record is Terminated.

Recall record

Recall number: Z-2389-2010
Status: Terminated
Initiated: 2010-08-02
Posted: 2010-09-09
Terminated: 2012-07-02
Recalling firm: Siemens Healthcare Diagnostics Inc.
Product: SYNCHRON Systems Modular Creatinine (CREm) Reagent Kit, Part Number: 472525 Systems AQUA CAL 1 and 2, is intended for the quantitative determination of creatinine concentration in human serum, plasma or urine. CREm reagent, when used in conjunction with SYNCHRON LX System(s), UniCel DxC 800 System and SYNCHRON Systems AQUA CAL 1 and 2, is intended for the quantitative determination of creatinine concentration in human serum, plasma or urine.
Product code: CGX Alkaline Picrate, Colorimetry, Creatinine
Reason for recall: The recall was initiated after Beckman Coulter confirmed reports that black / brown particulates were observed in some bottles of the Creatinine Alkaline Buffer (Buffer lot M911427 and M911518) in modular Creatinine (CREm) reagent kit lots M911428 and M911519. Beckman Coulter have had reports of erroneous results when using the lots of Creatinine Alkaline Buffer listed above. Single creatinine d
FDA root cause: Pending
Action: The firm, Beckman Coulter, sent a "URGENT: PRODUCT CORRECTIVE ACTION" letter dated August 3, 2010, to all customers. The letter describes the product, problem, and action to be taken by customer. The customers were instructed to: (1) Please discontinue use of Creatinine (CREm) reagent kit lots M911428 and M911519 and discard appropriately. (2) Please contact Beckman Coulter at (800) 526-3821 in the United States or (800) 463-7828 in Canada to discuss CREm kit M911428 and M911519 replacement options. Outside the United States and Canada, please contact your local Beckman Coulter Representative. (3) Please complete and return the enclosed response form within 10 days so that we may maintain our records. (4) Please share this information with their laboratory staff and retain this notification as part of their Quality System documentation. If you have forwarded the affected products listed above to another laboratory, please provide a copy of this letter to them. If customers have any questions regarding this Product Corrective Action letter, they were instructed to please contact Beckman Coulter's Customer Support Center (Call Center) on the Beckman Coulter website at www.BeckmanCoulter.com/Customer Support/Support Requests, or call (800) 854-3633 in the United States and Canada.
Quantity in commerce: 3106 units
Distribution: Worldwide Distribution - USA including the states of AL, AR, AZ, CA, CO, CT, DC, DE, FL, GA, HI, IA, ID, IL, IN, KY, KS, LA, MA, ME, MD, MI, MN, MO, MS, NC, ND, NE, NJ, NM, NV, NY, OH, OK, OR, PA, RI, SC, TN, TX, VA, WA, WI, WV, and WY and country of Canada
Product codes and lots: Lot Number(s): M911428 & M911519

Product code CGX

K965240Class ISynchron Lx 20 Clinical Chemistry System, Synchron Lx Albumin Reagent, Synchron Lx Creatinine Picric Reagent, Synchron LBeckman Instruments, Inc. / cleared 1997-03-10

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 2026-10-07, the FDA export date for this dataset. Page last changed 2026-09-05. View this recall on fda.gov (opens on fda.gov)