FDA Device recall Z-0989-2013
VITEK 2 60 computer system when equipped with the following Hewlett-Packard PC models: (1) rp5700, Cat. #W0452
- FDA Device
- Class II
- terminated
- Published 2013-04-03
On 2013-04-03 the FDA classified a Class II recall of VITEK 2 60 computer system when equipped with the following Hewlett-Packard PC models: (1) rp5700, Cat. #W0452 by Biomerieux, citing there is a potential to link an isolate result to the wrong patient and then upload the results to the LIS.
Read the official FDA Device notice
| Agency | FDA Device |
|---|---|
| Recall number | Z-0989-2013 |
| Classification | Class II |
| Status | terminated |
| Initiated | 2013-02-18 |
| Published | 2013-04-03 |
| Last updated | 2026-09-13 11:53 UTC |
| Company | Biomerieux |
| Distribution | US |
Product
VITEK 2 60 computer system when equipped with the following Hewlett-Packard PC models: (1) rp5700, Cat. #W0452; (2) rp5700 (refurbished), Cat. #W0452R; (3) rp5800 XPE, Cat. 413642; (4) rp5800 WES7, Cat. #413862; (5) dc7100 8-port, Cat. #W0441; (6) dc7100 8-port (refurbished), Cat. #W0441R; (7) dc7700 8-port, Cat. #W0447; (8) dc7700 8-port (refurbished), Cat. #W0447R; (9) dc7800, Cat. #W0449; and (10) dc7800 (refurbished), Cat. #W0449R. VITEK 2 is an automated system designed for the identification and antimicrobial susceptibility testing of bacteria and yeast.
Reason
There is a potential to link an isolate result to the wrong patient and then upload the results to the LIS.
Identifiers
| code_info | Manufactured from September, 2004, to present. |
|---|
Status history
No status changes recorded since RecallRadar first saw this recall on 2026-09-13 11:53 UTC. Current status: terminated.
Source
Official record: https://api.fda.gov/device/enforcement.json?search=recall_number:%22Z-0989-2013%22
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