Recalls / —

—#168251

Product

bioMrieux NucliSENS easyMAG Lysis Buffer ref. 280134

FDA product code

PPM — General Purpose Reagent

Device class

Class 1

Medical specialty

Pathology

Affected lot / code info

Lot Z019EA1LB Exp. 28-MAY-2019.

Why it was recalled

Some eluates become colored because of remaining hemoglobin in the eluate.

Root cause (FDA determination)

Nonconforming Material/Component

Action the firm took

Required Actions We request you to take the following actions at this time: -Please distribute this information to all appropriate personnel in your laboratory, retain a copy in your files, and forward this information to all parties that may use this product, including others to whom you may have transferred our product. -Stop using the NUCLISENS Lysis Buffer, Ref. 280134, Lot: Z019EA1LB, exp. 28-MAY-2019, and destroy any stock of this lot Z019EA1LB you might have in your laboratory. -Discuss any concern you may have regarding previously reported results with your Laboratory Medical Director to determine the appropriate course of action. -Contact your local bioMerieux, Inc. Customer Service representative if you have observed the issue and if you have a doubt regarding your results. -Complete the attached Acknowledgement Form in Attachment A to confirm receipt of this notice and return it to your local bioMrieux, Inc. representative. bioMrieux, Inc. is committed to providing our customers with the highest quality product possible. We sincerely apologize for any inconvenience that this may have caused your business. If you require additional assistance or have any questions, please contact your local bioMrieux, Inc. Clinical Customer Service representative at (800) 682-2666 or Industry Customer Service representative at (800) 634-7656. For non-urgent inquiries, please contact the Clinical Technical Support Center by email at CustomerService-ImmunoMolecular@biomerieux.com. The anticipated turnaround time for email inquiries is 24-48 hours during normal business hours (7AM 7PM EST), and up to 72 hours dependent upon weekends and company observed holidays.

Recalling firm

Firm

bioMerieux, Inc.

Address

100 Rodolphe St, Durham, North Carolina 27712-9402

Distribution

Distribution pattern

CA, FL, GA, MD, MI, MN, NC, NJ, NM, NY, OH, OR, RI, SC, TN, TX, VA, WA, and WI Austria, Australia, Belgium, Switzerland, Colombia, Germany, Spain, France, UK, India, Italy, Japan, Netherlands, Portugal, Sweden, Singapore, South Africa, Israel, Dutch Antilles, Angola, Estonia, and Bangladesh

Timeline

Recall initiated

2018-10-08

Terminated

2021-05-21

Status

—

Source: openFDA Device Recall endpoint. Recall record ID #168251. The FDA issues recall classifications as health-hazard assessments, not legal findings; for legal claims consult a licensed attorney.