APhL HRP IgM ELISA Kit; Ref. #LAPL-K-HRP-001M; distributed by Louisville APL Diagnostics, Inc., Doraville, GA 30360-- Quality Control Fact Sheets for the Louisville APL Diagnostics, Inc. --(current address now in Seabrook, TX 77586).
This recall has been terminated (originally issued August 17, 2007).
- Company
- Louisville Apl Diagnostics Inc
- Recall Initiated
- October 6, 2005
- Posted
- August 17, 2007
- Terminated
- October 11, 2007
- Recall Number
- Z-1177-2007
- Quantity
- 18 IgM test kits.
- Firm Location
- Seabrook, TX
- Official Source
- View on FDA website ↗
Reason for Recall
Mislabeling: Errors (control values) identified in the QC Fact Sheet for a specific lot of APhL HRP IgG and IgM test kits.
Distribution
World Wide: Product distributed to direct accounts in CA, FL and GA. Foreign consignees located in Canada and Turkey.
Lot / Code Info
Lot #050723
Root Cause
Other
Action Taken
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.
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