DiaSorin ETI-ANA Screen Kit, 96 Test, Model Number N0093, manufactured by Bio-Rad Laboratories.
- Company
- Bio-Rad Laboratories Inc
- Recall Initiated
- March 1, 2010
- Posted
- March 2, 2011
- Terminated
- March 11, 2011
- Recall Number
- Z-1478-2011
- Quantity
- 999 kits
- Firm Location
- Hercules, CA
Reason for Recall
Inaccurate results-- Consumer complaints of increased positivity rates with the ANA screening kit.
Distribution
Foreign Only: One distributor, DiaSorin S.R.I. in Italy. No wholesalers. No retailers. No domestic distribution, No Federal Government sales/distribution centers.
Lot / Code Info
Model number N0093, manufacture dates 09/17/2009 and 10/12/2009, lot numbers 24592003and 24592035.
Root Cause
Nonconforming Material/Component
Action Taken
Recall was initiated on 3/1/2010. DiaSorin S.R.I. (the sole consignee) was alerted via email using the firm's Medical Device Recall Notification. Consignee informed of the recall and instructed to dispose of the affected product according to local laws.
More recalls by Bio-Rad Laboratories Inc
Resin UPDATE CD-ROM, REF: 250-3020 inside VARIANTnbs Sickle Cell Program Reorder Pack, REF: 250-3000
Apr 7, 2022
D-10 Rack Loader;
Model Number 220-0600;
Hematology: The D-10 is a fully integrated system for samp...
Jan 27, 2016
Variant II beta-thalassemia Short Program Model Numbers 270-2103 (250 tests) and 270-2154 (500 tests...
May 2, 2014