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FDA (Device enforcement)Recalled 2022-03-09closedclass ii

Becton Dickinson & Co.: BD Synapsys Microbiology Informatics Solution, Catalog Number 444150, Software Version 4.10

Is my product affected?

BD Synapsys Microbiology Informatics Solution, Catalog Number 444150, Software Version 4.10

  • UPC 00382904441500

Check against the official notice below — it lists the full affected range.

What happened

Becton Dickinson & Co. is recalling BD Synapsys Microbiology Informatics Solution software version 4.10 (catalog number 444150) due to a hazard affecting 15 systems worldwide. When customers upgraded their BD Kiestra systems to version 4.10, the software overwrote their custom antibiotic codes with BD's default antibiotic codes, potentially affecting microbiology testing results.

The affected systems were distributed in California, Illinois, Michigan, New York, Ohio, South Carolina, and Tennessee in the United States, as well as in Austria, France, Germany, the Netherlands, and Sweden. The recall includes specific serial numbers ranging from SL00001 to SL01022. The source does not specify what remedy an affected consumer should take.

Written by software from the official notice below. Not reviewed by a lawyer.

Hazard

When updating BD Kiestra customers to BD Synapsys version 4.10, the custom antibiotic codes set by the customer are overwritten with the BD default antibiotic codes.

Details from the source

Reason for recall: When updating BD Kiestra customers to BD Synapsys version 4.10, the custom antibiotic codes set by the customer are overwritten with the BD default antibiotic codes. Distribution: Worldwide distribution US Nationwide distribution in the states of CA, IL, MI, NY, OH, SC, and TN. The countries of Austria, France, Germany, Netherlands, Sweden. Quantity: 15 systems Lot/code info: All systems running BD Synapsys version 4.10; UDI: 00382904441500; Serial Numbers: SL00530 SL00515 SL00527 SL00502 SL00540 SL00564 SL00549 SL00509 SL00003 SL00004 SL00010 SL00001 SL00005 SL00002 SL000015 SL01010 SL01022

Source

Official record: FDA (Device enforcement) ↗

Republished from the official source above; details can change — the source record controls.

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