Recall Z-0452-05 ยท LCX Kit, Test, Pregnancy, Hcg, Over The Counter
International Chemical Inc.
OTC Pregnancy Test labeled ''CHOICE Pregnancy Test Kit'' (PA-410A), midstream, no cups or droppers. Label reads: ''One Step, Easy to Use, Positive result as early as 1 minute, Over 99% accurate.'' Each box contains one home test kit. Responsible firm on label: Distributed by ICC, Amherst, NY 14228.
| Date | Jan 28, 2005 (initiated Oct 7, 2004) |
| Status | Terminated |
| Reason | Poor sealing of pouches and degradation of product. Invalid test results and false negatives are possible. |
| Root cause | Other |
| Action | The consignee (exporter) was notified via telephone in October 2004 regarding lot U040904 (cassette) and notified via telephone regarding the expanded recall (lot U060804, One-Step) on 12/27/2004. A recall letter issued regarding both lots on 1/10/2005. |
| Quantity | 150 kits |
| Distribution | Product was shipped to an exporter in Florida who further distributed to consignees in the Caribbean. |
| FDA record | Open on fda.gov |
510(k) clearances named in this recall
This recall record lists no 510(k) number.