VITEK 2 XL computer system when equipped with the following… — Class II medical device recall Z-0990-2013
Terminated recall by Biomerieux Inc, reported 2013-04-03, distributed nationwide. There is a potential to link an isolate result to the wrong patient and then upload the results to the LIS.
| Recall number | Z-0990-2013 |
|---|---|
| Product type | Medical device |
| Classification | Class II |
| Status | Terminated |
| Voluntary or mandated | Voluntary |
| Recalling firm | Biomerieux Inc, Hazelwood, MO, United States |
| Recall initiated | 2013-02-18 |
| Classified | 2013-03-25 |
| Reported by FDA | 2013-04-03 |
| Terminated | 2014-08-14 |
| Distributed | Nationwide (US) |
| Countries outside the US | AE, AR, AT, AU, BE, BG, BH, BO, BR, CA, CH, CL, CN, CO, CR, CZ, DE, DO, DZ, EC, EG, ES, FI, FR, GB, GR, GT, HN, HR, HU, ID, IE, IL, IN, IQ, IT, JO, JP, KE, KR, KW, LB, LT, LV, MA, MX, MY, NG, NI, NL, NO, OM, PA, PE, PH, PL, PT, PY, QA, RO, RS, RU, SA, SE, SG, SI, SV, TH, TN, TR, UA, UY, VE, VN, ZA |
| Model numbers | 413642, 413862, RP5700, W0441, W0441R, W0447, W0447R, W0449, W0449R, W0452, W0452R |
Product
VITEK 2 XL 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 for recall
There is a potential to link an isolate result to the wrong patient and then upload the results to the LIS.
Machine access
This record, with every extracted code, the verbatim FDA record and provenance, is available from the recall API: GET https://api.data.aroqon.com/v1/recalls/Z-0990-2013. Look up any UPC, UDI, NDC or lot with /v1/recalls/lookup?code=…. API docs · free and paid keys.
Source: U.S. Food and Drug Administration enforcement report via openFDA (CC0). Structured by Data Foundry (recall-structuring@2); last changed 2026-09-26. Not affiliated with or endorsed by FDA. Not medical or legal advice.