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Terminated

Becton, Dickinson and Company, BD MAX (tm) (6 channel) Instruments, Catalog number 441916, clinical diagnostic instrument.

FDA Recall Z-0701-2013 · Posted 2013-01-22

Recalling FirmBecton Dickinson & Co.
Recall StatusTerminated
Product CodeNJR
Date Initiated2012-09-18
Date Terminated2013-02-04
Product Quantity86 Instruments

Reason for Recall

Clinical diagnostic instrument may exhibit minor defects, which could lead to erroneous test results.

Firm Action

Becton Dickinson sent an Urgent Field Corrective Action letter September 18, 2012,by fax. The letter identified the product, the problem, and the action to be taken by the customer. Customers were advised that BD Field Service Associates will contact them within 7-10 days of the notification to determine if their instrument is impacted. Customers were requested to return a response form indicating the serial number on their instrument. If customers needed further assistance they were instrycted ti contact BD Technical Services Department at 1-800-638-8663. For questions regarding this recall call 410-316-4054.

Root Cause

Device Design

Distribution Pattern

USA including CT, FL, IL, KS, MD, MI, MO, NY, PA, RI, TX and WI. Internationally to Canada, Europe and Japan.

Related FDA 510(k) Records

Devices referenced by this recall via K-numbers.

K111860BD MAX GBS ASSAY, BD MAX INSTRUMENTBecton, Dickinson & CO · 2012-02-16

Official Source

View FDA Recall →

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

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