FDA Medical Device Recalls (openFDA)
Nichols Institute Diagnostics: Hyperglycosylated Human Chorionic Gonadotropin (H-hCG) Assay Cartridges (Catalog#62-7039)
- Recall number
- Z-0007-06
- Recalling firm
- Nichols Institute Diagnostics
- Product
- Hyperglycosylated Human Chorionic Gonadotropin (H-hCG) Assay Cartridges (Catalog#62-7039)
- Status
- Terminated
- Initiated
- 2005-08-31
- Posted
- 2005-10-06
- Terminated
- 2012-03-16
- Reason
- Data from internal testing indicates that the Nichols Advantage Invasive Trophoblast Antigen Assay Cartridges (ITA)(Lot No 62-500261) and Hyperglycosylated Human Chorionic Gonadotropin Assay Cartridges (H-hCG)(Lot No 62-500262) does not maintain its stability over the 12 month expiration dating of the product, and that stability is assured only through 6 months.
- Root cause
- Other
- Action
- Withdrawal letter was sent 08/30/2005 which request customers to stop using the product immediately and discard any remaining materials. A response card was included.
- Quantity
- 174
- Distribution
- Nationwide and China, Germany, & Australia
- Lot, serial or model codes
- Lot #62-500262
- 510(k) numbers
- ["K042676"]
- PMA numbers
- not on file
- Product code
- DHA
- Firm FEI
- 2050095
- Firm city
- San Clemente
- Firm state
- CA
- Firm country
- not on file
Where this comes from
- Register
- FDA Medical Device Recalls (openFDA)
- Publisher
- U.S. Food and Drug Administration (openFDA)
- File
- device-recall-0001-of-0001.json.zip
- sha256
- b87518bfe2e8
- Size
- 288210821 bytes
- Published
- 2026-09-28
- Read
- 2026-09-29T08:25:23.626Z
- Source file
- Source file retained · verify
- Refresh due
- 2026-10-06
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Cite as
FDA Medical Device Recalls (openFDA) (U.S. Food and Drug Administration (openFDA)), device-recall-0001-of-0001.json.zip, sha256 b87518bfe2e8, published 2026-09-28