Software version 4.44A utilized on the BD MAX System

FDA device recall Z-1864-2017 · posted 2017-04-04 · Terminated

Recall details

Recalling firm

BD LIFE SCIENCES

Reason for recall

The BD MAX System software version 4.44A contains a software anomaly that has the potential to affect some Open System Reagent (OSR) customers utilizing User Defined Protocol (UDP) assays. Customers utilizing only IVD assays are not affected. This anomaly may cause the OSR customer system to incorrectly switch the columns of the truth table on the users display. If the user tries to fix their display data, the display will appear correct however, the database may become incorrect, potentially resulting in incorrect results reporting. BD is able to trace the issue to a limited number of instruments that have software version 4.44A installed. Note that the problem only affects customers that are either creating a new UDP with Result Logic or modifying the Result Logic of an existing UDP.

Action taken

BD sent an Urgent Field Corrective Action Recall notification was initiated on July 29, 2015. The customer was initially contacted via a phone call and subsequently provided with a written communication. All US customers were contacted directly by phone and provided the written communication. Global holds were placed on July 21, 2015 and July 24, 2015. For further questions, please call (410) 316-4000.

Root cause

Software design

Status

Terminated

Product code

NSX

Quantity affected

There are 29 US customers and 5 ex-US regions with a BD MAX System running software version 4.44A.

Distribution

Worldwide Distribution - US Distribution to the states of : CA, CO, FL, IL, MN, MO, MT, NE, NJ, NY, OH, OR, PA, TX, TN, WA, WI., and to the countries of : Canada, Hong Kong, Taiwan, Turkey and Europe.

Date initiated

2015-07-29

Date posted

2017-04-04

Date terminated

2017-04-19

Location

Sparks Glencoe, MD

Related 510(k) clearances