—#93640

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.

FDA product code: CGX — Alkaline Picrate, Colorimetry, Creatinine
Device class: Class 2
Medical specialty: Clinical Chemistry
510(k) numbers: K965240
Affected lot / code info: Lot Number(s): M911428 & M911519

Why it was recalled

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

Root cause (FDA determination)

Pending

Action the firm took

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.

Recalling firm

Firm: Beckman Coulter Inc.
Address: 200 S Kraemer Blvd, Brea, California 92821-6208

Distribution

Distribution pattern: 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

Timeline

Recall initiated: 2010-08-02
Posted by FDA: 2010-09-09
Terminated: 2012-07-02
Status: —

Source: openFDA Device Recall endpoint. Recall record ID #93640. The FDA issues recall classifications as health-hazard assessments, not legal findings; for legal claims consult a licensed attorney.