Sm ELISA Test System Product number 2Z2831G and Product number 43270CE Individual Enzyme-Linked Immunosorbent Assays for

FDA device recall Z-1089-2009 · posted 2009-03-31 · Terminated

Recall details

Recalling firm

Zeus Scientific Inc

Reason for recall

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.

Action taken

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.

Root cause

Employee error

Status

Terminated

Product code

LJM

Quantity affected

33 of lot 08041819, 27 of lot 08041811.

Distribution

Nationwide Distribution

Date initiated

2008-08-19

Date posted

2009-03-31

Date terminated

2009-04-30

Location

Somerville, NJ

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