Recall Z-1209-03 ยท LJC Enzyme Linked Immunoabsorbent Assay, (Chlamydiae Group)
bioMerieux
VIDAS Chlamydia Assay (CHL) for In-Vitro Diagnostic Use Product Number: 30101
| Date | Oct 15, 2003 (initiated Aug 6, 2003) |
| Status | Terminated |
| Reason | Product's decrease in sensitivity may result in false negative results |
| Root cause | Other |
| Action | On August 6, 2003, Biomerieux''s recall letter and customer response form was sent to all US Customers and Biomerieux Global Customer Service in France, who is responsible for notification to all non-US bioMerieux subsidiaries. Non-US subsidiaries/distributors are responsible for notifying non-US Customers. VIDAS Chlamydia (CHL) Assay (product number 30 101) with Lot numbers 040212-0 and 040218-0 will be destroyed in the field. |
| Quantity | 2204 |
| Distribution | Nationwide NY, PA, IL, NJ, MO, NJ, NC, MI, WV, MD, CA, IN, MN, FL, WA, KS, GA, AZ, IA, SD, WI, SC, MT, TX, AK, OK, VA, CO, AL, OH, AR, MA, ND, CT, HI International: Japan, Argentina, Brazil, Chile, China, Columbia, Korea, Mexico, Canada, SA |
| FDA record | Open on fda.gov |
510(k) clearances named in this recall
| K915884 | VIDAS CHLAMYDIA ASSAY, MODIFICATION Vitek Systems, Inc., Mar 4, 1992 |