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Terminated

NucliSENS Magnetic Extraction Reagents

FDA Recall Z-0218-2019 · Posted None

Recalling FirmBioMerieux SA
Recall StatusTerminated
Product CodePPM
Date Initiated2018-09-17
Date Terminated2020-05-18
Product Quantity42 units

Reason for Recall

Data loggers showed that one shipment to the United States experienced low temperatures that may impact performance of this product.

Firm Action

bioMerieux notified customers on about 09/17/2018 via "URGENT PRODUCT REMOVAL NOTICE". Instructions included the following. 1. Confirm this information has been distributed to, and reviewed by, all appropriate personnel within your organization. Retain a copy of this letter for your files, and forward this information to all parties that may use this product, including others to whom you may have transferred this product. 2. Please discontinue use and destroy any impacted product remaining in your local inventory and contact your local bioMrieux, Inc. representative for credit. 3. Among tests previously performed with these batches, we advise you to discuss patients results: identify any possible false results, retest impacted samples when possible, analyze the related risks and determine appropriate actions if relevant. 4. Complete the attached Acknowledgement Form in Attachment A to confirm receipt of this notice and return it to your local bioMrieux, Inc. representative. Questions and concerns can be directed to Clinical Customer Service representative at (800) 682-2666 or Industry Customer Service representative at (800) 634-7656.

Root Cause

Other

Distribution Pattern

Nationwide distribution to MD, TX, MA, GA, OH, OR, CA, and WA.

Official Source

View FDA Recall →

Source: FDA Enforcement Report / Recall database. Always confirm against the official FDA record.

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