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Recall of OPD Tablets Component of Ortho HCV Elisa,
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DATE RECALL INITIATED: March 19, 2003 PRODUCT / LOT NUMBER: OPD Tablets, lot number 1C273 packaged as a component of the following ELISA Test Systems: Ortho HCV Version 3.0 ELISA Test System, lot number TXE358 Ortho Antibody to HBsAg ELISA Test System 2, lot number 2HB567 Ortho HBc ELISA Test System, lot numbers CHK423 and CHK424 MANUFACTURER:
Ortho-Clinical Diagnostics REASON: Ortho-Clinical Diagnostics is recalling OPD Tablets that are packaged as components of Ortho ELISA Test Systems after receiving information that the OPD tablets may be discolored. Results of an investigation conducted by the manufacturer disclosed that if yellow or discolored OPD tablets are inadvertently used, the assay controls may be out of the acceptable range criteria as stated in the package insert resulting in an invalid plate. The PRECAUTIONS section of the package inserts state, "Do not use tablets that are yellow (discolored) or broken." The OPD Tablets are packaged in the following test systems: Ortho HCV Version 3.0 ELISA Test System, lot number TXE358; Ortho Antibody to HBsAg ELISA Test System 2, lot number 2HB567; and Ortho HBc ELISA Test System, lot numbers CHK423 and CHK424. Establishments are instructed that tablets that appear normal (i.e., not discolored or broken) are acceptable for use until the receipt of OPD replacement tablets from the recalling firm. Test results obtained from valid plates (plates that meet package insert quality control acceptance criteria) are acceptable.
The information in this listing reflects CBER's best efforts to communicate information that has been reported to FDA. Its accuracy and comprehensiveness cannot be guaranteed.
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