Immulite 2000 H. pylori IgG Kit lot 118 (L2KHQ6, 600 test size kit)
FDA Recall Z-1219-03 · Posted 2003-09-11
Recalling FirmDiagnostic Products Corp
Recall StatusTerminated
Product CodeLYR
Date Initiated2003-07-31
Date Terminated2003-12-30
Product Quantity339
Reason for Recall
Kits had parts in them that did not belong in the kit.
Firm Action
Customers have been informed to discard kits with the incorrect adjustors in them by fax delivered on 7/31/2003.
Root Cause
Other
Distribution Pattern
US, Italy, Turkey, Czech Republic, Poland, Sweden, Canada, Germany and Austria
Related FDA 510(k) Records
Devices referenced by this recall via K-numbers.
Official Source
View FDA Recall →Source: FDA Enforcement Report / Recall database. Always confirm against the official FDA record.