OTC Pregnancy Test Kit labeled: ''CHOICE Pregnancy Test Kit'' (PA-320) , cassette type with cup and dropper. Label state
FDA device recall Z-0453-05 · posted 2005-01-28 · Terminated
Recall details
- Recalling firm
- International Chemical Inc.
- Reason for recall
- Poor sealing of pouches and degradation of product. Invalid test results and false negatives are possible.
- Action taken
- 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.
- Root cause
- Other
- Status
- Terminated
- Product code
- LCX
- Quantity affected
- 108
- Distribution
- Product was shipped to an exporter in Florida who further distributed to consignees in the Caribbean.
- Date initiated
- 2004-10-07
- Date posted
- 2005-01-28
- Date terminated
- 2005-10-13
- Location
- Amherst, NY
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