Zeus Scientific Inc Recalls
Showing 1-7 of 7 recalls
Sm ELISA Test System Product number 2Z2831G and Product number 43270CE Individual Enzyme-Linked Immunosorbent Assays for Antibodies to Jo-1, SM, SM/RNP, SSA, SSB and Scl-70. Manufactured by Zeus Scientific, Raritan, NJ 08869-0038. Also manufactured for Wampole Laboratories, Princeton, NJ 08540 Semi-quantitative immunoassays for the detection of IgG antibodies to Jo-1, Sm, Sm/RPN (Ro), SSB(La) and Scl-70 in human sera. This device is for in-vitro diagnostic use.
The Calibrator Value is printed incorrectly on the Sm ELISA Test System, lot # 08041819. The Calibrator Value (CV) printed on the label is 102; the correct CV should read 266.
Urgent Recall Notice letters were sent out by Federal Express night mail on August 19, 2008 to all direct account. Wampole (Inverness) will notify their customers in a separate letter. Recall letters explained the reason for the recall and that the product does meet the company's criteria when it is used qualitatively to interpret index values or OD rations as outlined in the kit package insert. Customers are advised in the letter that the Calibrator Value of 102 is incorrect and that it should be 266. Instructions to correctly express the specimen results using specimen and calibrator OD values semi-qualitatively as Unit Values and the Calibrator Value (CV) or 266 are included. Letters also state that results for all patients using the incorrect CV of 102 should be recalculated using the correct CV of 266. All letters included a fax back form indicating that they have received the recall notification, have notified customers to correct the CV value for the Semi-Quantitative Conversion and have notified customers that have received the kit to correct the Semi-Quantitative Conversion of Optical Density to AAU/mL for the affected lot number of the Sm ELISA Test System.
Rheumatoid Factor ELISA Test Kit. Labeled under the following names: Sigma Diagnostics, Inc, Saint Louis, MO and Zeus Scientific, Inc Branchburg, NJ.
Calibrator C not meeting its optical density specification.
Customers were notified of the recall via DHL on 11/9/2001. Customers were instructed to return or destroy product.
Measles (Rubeola) IgG ELISA Test System. It is an enzyme-linked immunosorbent assay (ELISA) designed for the qualitative detection of IgG antibodies to Measles (Rubeola) virus in human serum and is for in vitro diagnostic use. Product Number: 507055
Mix-up between low positive and negative controls.
Recall letter was sent via DHL to Biotest on 3/19/2001. Product was to be returned to Zeus.
Cardiolipin IgM ELISA Test System, Product Number 438450CE. The test kit consists of a test plate, and various reagents in individual vials (positive and negative controls, calibrator, diluent, substrate, stop solution, wash buffer.). The individual vials are secured in the card board box. The test kit which is coated with the appropirate antigen, are placed in a foil pouch, which is also placed in the middle of the cardboard box.
During packaging, Lyme plates were packaged in this kit in error.
Wampole Laboratories was contacted by Zeus on 8/30/3004. Wampole customers were then contacted by phone and letter to destroy all products on hand.
Cytomegalovirus (CMV) IgG ELISA Test System, In-Vitro Diagnostic, manufactured by Zeus Scientific, Inc., Raritan, NJ.
The Calibrator included within the kit may be losing reactivity.
All customers were notified via recall letter on June 12, 2003. Letter sent out via Airborne Express. All product is to be returned to Zeus or destroyed.
Rubella IgM ELISA Test Kit. It is an enzyme-linked immunoabsorbent assay designed for the qualitative detection of IgM antibodies to Rubella virus in human serum. 1 kit (96 tests). Prepared for Sigma Diagnostics, Inc., St. Louis, MO 63178. EIA514-B
The high positive control/low positive standard ratio recovering too low.
Recall letters sent out via DHL on 2/24/2000
Anti-Cardiolipin IgA ELISA test kit. Product is manufactured by Zeus Scientific, Branchburg, NJ for Sigma Diagnostics, Inc., Saint Louis, MO.
Bacterial contamination of the high positive control.
Recall letter were sent via DHL to consignee on 6/22/2001 which instructed to return or discard any remaining inventory.