FDA (Devices) recall action 65470

Biomerieux Inc recalled 15 products on 2013-08-14

The FDA (Devices) publishes a recall like this one as 15 separate product records. They share a firm, a date and a cause; this page is all of them in one place, so the scale of the action is visible rather than spread across 15 pages.

Products: 15
Announced: 2013-08-14
Critical: 0
Units: 185,760

Why these products were recalled

A product issue has been identified for customers using software version 6.01 and are interfaced with a Laboratory Information System (LIS). During the update of software from version 5.xx to 6.01, the Bid-directional Computer interface (BCI) antibiotic codes are not updated properly for Cefovecin, Prulifloxacin and Ceftaroline. For the referenced antibiotics, the firm code in the reference table

The agency’s own wording, quoted from the enforcement report.

The unit total adds up the quantities the agency stated for each product. Where a product record gave no figure, or gave a weight rather than a count, it contributes nothing — so the real total is at least this, never less.

1–15 of 15

ModerateFDA (Devices)··2013-08-14
BioMerieux Vitek 2 Software Version 6.01 Recalled for Interface Errors
BioMerieux Inc is recalling Vitek 2 Systems Software version 6.01 because antibiotic codes for three specific drugs are not updated correctly when interfacing with Laboratory Information Systems.
Product
bioMerieux Vitek 2 Systems Software version 6.01 software, used with the VITEK 2 automated system. Kit, UPDT V2S 6.01 ZH. Part number: 414569. The product is used with the VITEK 2 automated system which consists of instruments, software and reagent cards designed for the iden
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ModerateFDA (Devices)··2013-08-14
BioMérieux Vitek 2 Software Version 6.01 Recalled for Interface Errors
BioMérieux is recalling Vitek 2 software version 6.01 because antibiotic codes for three specific drugs are not updated properly when interfaced with Laboratory Information Systems.
Product
bioMerieux Vitek 2 Systems Software version 6.01 software, used with the VITEK 2 automated system. Kit V2S RP5800XPE TO 6.01 WES7. Part number: 6201773. The product is used with the VITEK 2 automated system which consists of instruments, software and reagent cards designed fo
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ModerateFDA (Devices)··2013-08-14
Biomerieux Vitek 2 Software Version 6.01 Recalled for Interface Errors
Biomerieux Inc. is recalling Vitek 2 Systems Software version 6.01 because specific antibiotic codes are not updated properly when interfaced with a Laboratory Information System.
Product
bioMerieux Vitek 2 Systems Software version 6.01 software, used with the VITEK 2 automated system. Kit, UPDT V2S 6.01 IT. Part number: 414563. The product is used with the VITEK 2 automated system which consists of instruments, software and reagent cards designed for the iden
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ModerateFDA (Devices)··2013-08-14
BioMerieux Vitek 2 Software Recall for Antibiotic Code Errors
BioMerieux is recalling Vitek 2 software version 6.01 because antibiotic codes for three specific drugs are not updated properly when interfaced with Laboratory Information Systems.
Product
bioMerieux Vitek 2 Systems Software version 6.01 software, used with the VITEK 2 automated system. Kit, UPDT V2S 6.01 ES. Part number: 414561. The product is used with the VITEK 2 automated system which consists of instruments, software and reagent cards designed for the iden
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ModerateFDA (Devices)··2013-08-14
BioMerieux Vitek 2 Software Recall for Antibiotic Code Errors
BioMerieux is recalling Vitek 2 software version 6.01 because specific antibiotic codes were not updated correctly during an upgrade, potentially affecting laboratory reporting.
Product
bioMerieux Vitek 2 Systems Software version 6.01 software, used with the VITEK 2 automated system. Kit, UPDT V2S 6.01ML2. Part number: 414538. The product is used with the VITEK 2 automated system which consists of instruments, software and reagent cards designed for the iden
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ModerateFDA (Devices)··2013-08-14
BioMérieux Vitek 2 Software Recall for Antibiotic Code Errors
BioMérieux is recalling Vitek 2 software version 6.01 because specific antibiotic codes are not updated correctly when interfaced with Laboratory Information Systems.
Product
bioMerieux Vitek 2 Systems Software version 6.01 software, used with the VITEK 2 automated system. Kit, UPDT V2S 6.01 PT. Part number: 414566. The product is used with the VITEK 2 automated system which consists of instruments, software and reagent cards designed for the iden
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ModerateFDA (Devices)··2013-08-14
BioMerieux Vitek 2 Software Version 6.01 Recalled for Interface Errors
BioMerieux is recalling Vitek 2 software version 6.01 because specific antibiotic codes are not updated properly when interfaced with Laboratory Information Systems.
Product
bioMerieux Vitek 2 Systems Software version 6.01 software, used with the VITEK 2 automated system. Kit, UPDT V2S 6.01 DE. Part number: 414539. The product is used with the VITEK 2 automated system which consists of instruments, software and reagent cards designed for the iden
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ModerateFDA (Devices)··2013-08-14
BioMérieux Vitek 2 Software Version 6.01 Recalled for Interface Errors
BioMérieux is recalling Vitek 2 Systems Software version 6.01 because antibiotic codes for three specific drugs are not updated properly when interfaced with Laboratory Information Systems.
Product
bioMerieux Vitek 2 Systems Software version 6.01 software, used with the VITEK 2 automated system. Kit, V2S 6.01 RP5800-WES7 Media. Part number: 413861. The product is used with the VITEK 2 automated system which consists of instruments, software and reagent cards designed fo
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ModerateFDA (Devices)··2013-08-14
BioMérieux Vitek 2 Software Recall for Antibiotic Code Errors
BioMérieux is recalling Vitek 2 Systems Software version 6.01 because specific antibiotic codes are not updated properly when interfaced with Laboratory Information Systems.
Product
bioMerieux Vitek 2 Systems Software version 6.01 software, used with the VITEK 2 automated system. Kit, UPDT V2S 6.01 DA, SV. Part number: 414567. The product is used with the VITEK 2 automated system which consists of instruments, software and reagent cards designed for the
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ModerateFDA (Devices)··2013-08-14
BioMerieux Vitek 2 Software Version 6.01 Recalled for Interface Errors
BioMerieux is recalling Vitek 2 software version 6.01 because antibiotic codes for Cefovecin, Prulifloxacin, and Ceftaroline are not updated properly when interfaced with Laboratory Information Systems.
Product
bioMerieux Vitek 2 Systems Software version 6.01 software, used with the VITEK 2 automated system. Kit, UPDT V2S 6.01 NO. Part number: 414565. The product is used with the VITEK 2 automated system which consists of instruments, software and reagent cards designed for the iden
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ModerateFDA (Devices)··2013-08-14
BioMerieux Vitek 2 Software Recall for Interface Code Errors
BioMerieux is recalling Vitek 2 software version 6.01 because antibiotic codes for three specific drugs were not updated correctly during the software upgrade.
Product
bioMerieux Vitek 2 Systems Software version 6.01 software, used with the VITEK 2 automated system. Kit, UPDT V2S 6.01ML1. Part number: 414537. The product is used with the VITEK 2 automated system which consists of instruments, software and reagent cards designed for the iden
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ModerateFDA (Devices)··2013-08-14
BioMérieux Vitek 2 Software Version 6.01 Recalled for Interface Error
BioMérieux is recalling Vitek 2 software version 6.01 because antibiotic codes for three specific drugs are not updated correctly when interfaced with Laboratory Information Systems.
Product
bioMerieux Vitek 2 Systems Software version 6.01 software, used with the VITEK 2 automated system. Kit, UPDT V2S 6.01 FR. Part number: 414562. The product is used with the VITEK 2 automated system which consists of instruments, software and reagent cards designed for the iden
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ModerateFDA (Devices)··2013-08-14
BioMérieux Vitek 2 Software Recall Due to Antibiotic Code Errors
BioMérieux is recalling Vitek 2 software version 6.01 because antibiotic codes for three drugs are not updated correctly when interfaced with laboratory systems.
Product
bioMerieux Vitek 2 Systems Software version 6.01 software, used with the VITEK 2 automated system. Kit, UPDT V2S 6.01 JA. Part number: 414564. The product is used with the VITEK 2 automated system which consists of instruments, software and reagent cards designed for the iden
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ModerateFDA (Devices)··2013-08-14
BioMerieux Vitek 2 Software Recall for Antibiotic Code Errors
BioMerieux is recalling Vitek 2 Systems Software version 6.01 because antibiotic codes for three specific drugs were not updated correctly during a software upgrade.
Product
bioMerieux Vitek 2 Systems Software version 6.01 software, used with the VITEK 2 automated system. Kit, UPDT V2S 6.01 EL, TR. Part number: 414568. The product is used with the VITEK 2 automated system which consists of instruments, software and reagent cards designed for the
Category
Distribution
0 states
ModerateFDA (Devices)··2013-08-14
BioMerieux Vitek 2 Software Recall for Antibiotic Code Errors
BioMerieux is recalling Vitek 2 software version 6.01 because specific antibiotic codes are not updated correctly when interfaced with Laboratory Information Systems.
Product
bioMerieux Vitek 2 Systems Software version 6.01 software, used with the VITEK 2 automated system. Kit, UPDT V2S 6.01 EN. Part number: 414560. The product is used with the VITEK 2 automated system which consists of instruments, software and reagent cards designed for the iden
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