Severity
Moderate
ModerateClass IITerminated
FDA Devices recall · Reported April 26, 2017
Software version 4.44A utilized on the BD MAX System
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…
Bd Life Sciences recalled Software version 4.44A utilized on the BD MAX System - a moderate-severity action.
Software version 4.44A utilized on the BD MAX System was recalled by Bd Life Sciences in April 26, 2017. Reason: The BD MAX System software version 4.44A contains a software anomaly that has the potential to affect some Op…. Check the official notice for the remedy. Verify recall #Z-1864-2017 with the FDA Devices before acting.
The recall
Bd Life Sciences issued this moderate-severity FDA Devices recall-The BD MAX System software version 4.44A contains a software anomaly that has the potential to affect some Op….
- Moderate
- severity level
- Class II
- classification
- April 26, 2017
- reported
Sourced from official FDA Devices enforcement records. Verify recall #Z-1864-2017 with the agency before acting. Full product description, hazard, remedy, and related recalls are below.
Recall Insight
This FDA Devices action (record #Z-1864-2017) was formally reported on April 26, 2017, with the manufacturer initiating the action on July 29, 2015. It is classified under Moderate severity (Class II), with a current status of Terminated. Bd Life Sciences is listed as the recalling firm, operating out of Sparks Glencoe, MD. Federal records list the affected scope as There are 29 US customers and 5 ex-US regions with a BD MAX System running software version 4.44A..
The documented reason for this recall is: 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 a… Distribution data in the federal record shows the product reached: 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. Federal Governm…. Distribution scope directly affects the consumer exposure window and determines whether a recall remains regional or escalates into a nationwide advisory.
Within the same product category the archive holds 6 closely related recalls, 3 from FDA Devices - clustering in a narrow category often points to a systemic quality-control or supplier issue rather than a one-off defect. Always verify the recall number against the official agency record before acting.
Medical Devices recalls over time
Where this recall sits in its category - 40,322 medical devices recalls on record
Of 101,704 recalls in the database, 24,878 are high severity, 72,426 moderate, and 4,400 low. This recall is classified moderate severity.
Counts reflect market size and reporting activity, not inherent danger, we do not rank products by risk from raw recall volume.
Affected scope
There are 29 US customers and 5 ex-US regions with a BD MAX System running software version 4.44A.
Related Recalls
6
3 from same agency
Product description
Software version 4.44A utilized on the BD MAX System
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.
Recall Profile
| Attribute | Value |
|---|---|
| Agency | U.S. Food and Drug Administration |
| Severity class | Moderate (Class II) |
| Status | Terminated |
| Recall number | Z-1864-2017 |
| Date reported | April 26, 2017 |
| Date initiated | July 29, 2015 |
| Recalling firm | Bd Life Sciences |
| Firm location | Sparks Glencoe, MD |
| Affected scope | 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. Federal Government Agency sales/dis… |
Profile values are sourced directly from the official FDA Devices enforcement record. Source: U.S. Food and Drug Administration.
What to do with this recall
Match your product against the recall record, then act on the agency remedy.
- Check the recall number (Z-1864-2017) and product description against the item you own. Search the archive
- Confirm the current status with FDA Devices before acting, recall details can be updated.
- Follow the documented remedy (refund, replacement, repair, or disposal) rather than general advice. What to do next
This page summarizes the official FDA Devices record for research and awareness; it is not legal, medical, or safety advice. Verify with the issuing agency before acting.
Frequently Asked Questions
What product was recalled? ▼
Software version 4.44A utilized on the BD MAX System. Recalled by Bd Life Sciences. Units affected: There are 29 US customers and 5 ex-US regions with a BD MAX System running software version 4.44A..
Why was this product recalled? ▼
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.
Which agency issued this recall? ▼
This recall was issued by the FDA Devices on April 26, 2017. Severity: Moderate. Recall number: Z-1864-2017.
Where was the recalled product distributed? ▼
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. Federal Government Agency sales/distribution centers or foreign countries VA Fort Harrison and VAMC Austin..
How do I check if my product is affected by a recall? ▼
Check the product description and recall number (Z-1864-2017) against your product. Visit the official FDA Devices website for the most current information. You can also use our Recall Checker tool to search by product name or brand.
Should I stop using a recalled medication or medical device? ▼
Do not stop using a recalled medication or device without consulting your healthcare provider first, as abruptly discontinuing treatment could pose its own health risks. Your doctor can advise on alternatives or whether the recall applies to your specific product lot. Check the recall number and lot information against your product packaging.
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Every figure on PlainRecalls is rendered directly from official FDA, CPSC and NHTSA recall records, no number is typed in by an editor. This recall: FDA Devices, reported April 26, 2017. Severity classes follow each agency's own taxonomy (FDA Class I/II/III; CPSC and NHTSA by hazard type), and related-recall context is computed across the full archive. See our editorial standards & corrections policy, the methodology behind these numbers, or report a data error. Data current as of July 2026.