Genesys Diluent Reagent, REF 01-03-0019 intended to be used with automated high performance liquid chromatography (HPLC) systems employing ion exchange chromatography. For in vitro diagnostic use only.
FDA Recall Z-0624-2019 · Posted None
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Recalling FirmClark Laboratories, Inc. (dba,Trinity Biotech USA)
Recall StatusTerminated
Product CodeGKA
Date Initiated2018-11-01
Date Terminated2022-06-21
Product Quantity463 units
Reason for Recall
lack of 510K
Firm Action
The firm initiated the recall by letter on 11/01/2018. The letter explained the problem and requested the return of the recalled items.
Root Cause
No Marketing Application
Distribution Pattern
IL, WV, NJ, AZ, MD, UT
Official Source
View FDA Recall →Source: FDA Enforcement Report / Recall database. Always confirm against the official FDA record.
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