Company: BioMerieux Inc.
Date of Enforcement Report 11/28/12
Class ll:
PRODUCT
1. bioMerieux Kit, Instrument & Update, 3D B.40 ZIP-ML01, Clinical instrument software, English, Spanish, Italian, catalog number 411814 Software update for the clinical instrument which is most commonly used to isolate and recover specimens drawn from adult and older pediatric patients that are acutely ill with signs and symptoms suggestive of blood stream infection, which can be due to a variety of sources including lung, abdomen, urinary tract, endovascular, and skin.
Recall Number Z-0302-2013 1336 kits
2. bioMerieux Kit, Instrument & Update, 3D B.40 ZIP-ML 02, Clinical instrument software, English, Spanish, Italian, catalog number 411815 Recall Number Z-0303-2013 860 kits
3. bioMerieux Kit, Instrument & Update, 3D B.40 BTA3D-ZH01, Clinical instrument software, Chinese, catalog number 411816 Recall Number Z-0304-2013 30 kits
4. bioMerieux Kit, Instrument & Update, 3D B.40 ZIP-ML03, Clinical instrument software, Danish, Greek, Polish, Portuguese, catalog number 412623 Recall Number Z-0305-2013 250 Kits
5. bioMerieux Kit, Instrument & Update, 3D B.40 ZIP-ML04, Clinical instrument software, Czech, Estonian, Hungarian, Romanian, catalog number 412624 Recall Number Z-0306-2013
6. bioMerieux Kit, Instrument & Update, 3D B.40 ZIP-ML05, Clinical instrument software, Lithuanian, Latvian, Russian, Slovak, catalog number 412625 Recall Number Z-0307-2013 163 kits.
7. bioMerieux Kit, Instrument & Update, 3D B.40 ZIP-ML06, Clinical instrument software, Japanese, Korean, Norwegian, Brazilian, Portuguese, Turkish, catalog number 412626 Recall Number Z-0308-2013 671 kits.
8. bioMerieux Kit, Instrument & Update, 3D B.40 USB-ML01, Clinical instrument software, English, Spanish, Italian, catalog number 411818 Recall Number Z-0309-2013 620 kits
9. bioMerieux Kit, Instrument & Update, 3D B.40 USB-ML02, Clinical instrument software, German, French, Swedish, catalog number 411925 Recall Number Z-0310-2013 556 kits.
10. bioMerieux Kit, USB Instrument & Update, 3D B.40 USB-ML03, Clinical instrument software, Danish, Greek, Polish, Portuguese, catalog number 412559 Recall Number Z-0314-2013. 29 kits.
11. bioMerieux Kit, Instrument & Update, 3D B.40 USB-ML04, Clinical instrument software, Czech, Estonian, Hungarian, Romanian, catalog number 412620 Recall Number Z-0315-2013 28 kits
12.bioMerieux Kit, Instrument & Update, 3D B.40 USB-ML05, Clinical instrument software, Lithuanian, Latvian, Russian, Slovak, catalog number 412621 Recall Number Z-0316-2013 12 kits
13. bioMerieux Kit, Instrument & Update, 3D B.40 USB-ML06, Clinical instrument software, Japanese, Korean, Norwegian, Brazilian, Portuguese, Turkish, catalog number 412622 Recall Number Z-0317-2013. 69 kits
14. bioMerieux Kit, Instrument & Update, 3D IND ZIP-ML 01, Industry instrument software update, English, Spanish, Italian, catalog number 412005 Recall Number Z-0321-2013. 288 kits.
REASON
The product may mislabel patient information on culture specimen bottles due to a software miscommunication.
RECALLING FIRM/MANUFACTURER
Biomerieux Inc., Hazelwood, MO on 10/16/2012 Voluntary: Firm Initiated recall is ongoing
VOLUME OF PRODUCT IN COMMERCE
see under product
DISTRIBUTION
Nationwide and Internationally
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