Recall Z-1089-2009 ยท LJM Antinuclear Antibody (Enzyme-Labeled), Antigen, Controls
Zeus Scientific Inc
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
| Date | Mar 31, 2009 (initiated Aug 19, 2008) |
| Status | Terminated |
| Reason | 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. |
| Root cause | Employee error |
| Action | 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 |
| Quantity | 33 of lot 08041819, 27 of lot 08041811. |
| Distribution | Nationwide Distribution |
| FDA record | Open on fda.gov |
510(k) clearances named in this recall
| K941409 | ENA PROFILE-6 ELISA TEST SYSTEM Zeus Scientific, Inc., Jun 10, 1994 |