Reported Apr 3, 2013 · Terminated
VITEK 2 Compact computer system when equipped with the following Hewlett-Packard PC models
Biomerieux Inc.
Moderate riskThis product could cause temporary or reversible health problems — stop using it.What you should do
Stop using the affected lot and contact the recalling firm for the return or refund process. Check the FDA enforcement report for lot-level detail.
Firm contact: Biomerieux Inc · 595 Anglum Rd · Hazelwood, MO · 63042-2320
Is this the product you have?
VITEK 2 Compact computer system when equipped with the following Hewlett-Packard PC models
12 of 12 products
| Model / number | Product as published |
|---|---|
W0441 | (1) dc7100 8-port |
W0441R | (2) dc7100 8-port (refurbished) |
W0447 | (3) dc7700 8-port |
W0447R | (4) dc7700 8-port (refurbished) |
W0449 | (5) dc7800 |
W0452 | (6) dc7800 (refurbished), Cat. #W0449R (7) rp5700 |
W0452R | (8) rp5700 (refurbished) |
| — | (9) rp5800 XPE, Cat. 413642 |
413862 | (10) rp5800WES7 |
W0438 | (11) d530 6-port |
W0438R | (12) d530 6-port (refurbished) |
W0437. | and (13) d530 4-port, VITEK 2 is an automated system designed for the identification and antimicrobial susceptibility testing of bacteria and yeast. |
- Lot codes and dates
- Manufactured from September, 2004, to present.
- Amount recalled
- For all 3 computers types: 16,736 originally distributed; 554 refurbished and redistributed
This recall covers 4 products
The agency filed one notice per product. You are reading one of them; the other 3 are below.
Where it was sold
Why it was recalled
There is a potential to link an isolate result to the wrong patient and then upload the results to the LIS.
This product could cause temporary or reversible health problems — stop using it.
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