FDA Medical Device Recalls (openFDA)
Roche Diagnostics Corp.: CoaguChek PT test strips, sold in 12 pack.
- Recall number
- Z-0720-03
- Recalling firm
- Roche Diagnostics Corp.
- Product
- CoaguChek PT test strips, sold in 12 pack.
- Status
- Terminated
- Initiated
- 2003-02-20
- Posted
- 2003-04-10
- Terminated
- 2003-11-10
- Reason
- Discrepancy between INR and the % Quick displayed on the meter.
- Root cause
- Other
- Action
- Customers in Germany were notified of the recall, and asked to return this lot of product. While the product is sold in many countries, Germany is the only country affected, since their results are the only ones reported as % Quick.
- Quantity
- 11412 containers
- Distribution
- Germany
- Lot, serial or model codes
- lot 533
- 510(k) numbers
- ["K974569"]
- PMA numbers
- not on file
- Product code
- JPA
- Firm FEI
- 1823260
- Firm city
- Indianapolis
- Firm state
- IN
- 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
Unless otherwise noted, the content, data, documentation, code, and related materials on openFDA is public domain and made available with a Creative Commons CC0 1.0 Universal dedication.
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