Recall Z-1100-06 ยท JHI Visual, Pregnancy Hcg, Prescription Use
Applied Biotech Inc
Signify hCG Serum/Urine 30 Test Kit, Abbott List No. 07K09-30, ABI List No. 6026KSI, Lot# 84936, Exp 02/10/2007
| Date | Jun 9, 2006 (initiated May 5, 2006) |
| Status | Terminated |
| Reason | 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. |
| Root cause | Other |
| Action | 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. |
| Quantity | 1198 Kits (35,940 Test) |
| Distribution | In US : IL |
| FDA record | Open on fda.gov |
510(k) clearances named in this recall
This recall record lists no 510(k) number.