Signify hCG Serum/Urine 30 Test Kit, Abbott List No. 07K09-30, ABI List No. 6026KSI, Lot# 84936, Exp 02/10/2007

FDA device recall Z-1100-06 · posted 2006-06-09 · Terminated

Recall details

Recalling firm

Applied Biotech Inc

Reason for recall

Certain kits from the product lot may contain test devices which contain incorrect reaction strips. Use of such devices may produce false negative results with patient samples at and above the limit of detection of the product.

Action taken

Distribution records indicate that the above product lot was produced for sale to Abbott Laboratories and Abbott Laboratories received all of the product lot. A recall certified recall letter was mailed 05/08/06. Abbott was also instructed if they have further distributed any of the referenced product lot, please see that their accounts are contacted, advise them of the urgent notification, and instruct them to destroy any of the affected product lot.

Root cause

Other

Status

Terminated

Product code

JHI

Quantity affected

1198 Kits (35,940 Test)

Distribution

In US : IL

Date initiated

2006-05-05

Date posted

2006-06-09

Date terminated

2012-02-29

Location

San Diego, CA