Disclaimer: This site aggregates publicly available data from official government sources (FDA, ClinicalTrials.gov, PubMed, SEC EDGAR) for general reference only. It does NOT constitute medical advice, diagnosis, treatment recommendations, or investment advice.

Terminated

APhL HRP IgG & IgM ELISA Kit; Ref. #LAPL-K-HRP-00GM; distributed by Louisville APL Diagnostics, Inc., Doraville, GA 30360- Quality Control Fact Sheets for the Louisville APL Diagnostics, Inc. (address now in Seabrook, TX 77586).

FDA Recall Z-1175-2007 · Posted 2007-08-17

Recalling FirmLouisville Apl Diagnostics Inc
Recall StatusTerminated
Product CodeMID
Date Initiated2005-10-06
Date Terminated2007-10-11
Product Quantity29 test kits (ea. kit containing 1 IgG and 1 IgM test kit)

Reason for Recall

Mislabeing : Errors (control values) identified in the QC Fact Sheet for a specific lot of APhL HRP IgG and IgM test kits.

Firm Action

Firm notified consignees of recall via fax on 05/05-06/2005. Consignees asked to replace Quality Control Fact Sheets shipped with test kits with the corrected Quality Control Fact Sheets provided with fax.

Root Cause

Other

Distribution Pattern

World Wide: Product distributed to direct accounts in CA, FL and GA. Foreign consignees located in Canada and Turkey.

Related FDA 510(k) Records

Devices referenced by this recall via K-numbers.

K933588APHLELISA KITLouisville Apl Diagnostics, Inc. · 1994-10-13

Official Source

View FDA Recall →

Source: FDA Enforcement Report / Recall database. Always confirm against the official FDA record.

↑