FDA Medical Device Recalls (openFDA)
Roche Diagnostics Corp.: CoaguChek brand PT Test Strips; U.S. catalog number 3116247 (professional use), 3116239 (patient self test), ex-U.S. catalog numbers 1937642 [packaged 48 strips per box] and 1937634 [packaged 12 strips per box].
- Recall number
- Z-1293-03
- Recalling firm
- Roche Diagnostics Corp.
- Product
- CoaguChek brand PT Test Strips; U.S. catalog number 3116247 (professional use), 3116239 (patient self test), ex-U.S. catalog numbers 1937642 [packaged 48 strips per box] and 1937634 [packaged 12 strips per box].
- Status
- Terminated
- Initiated
- 2003-09-12
- Posted
- 2003-10-15
- Terminated
- 2004-05-11
- Reason
- Erroneous patient results: may be falsely elevated or lowered, due to a packaging defect that allows air and moisture to enter the sealed pouch.
- Root cause
- Other
- Action
- Urgent recall letters dated 9/12/03 were sent to customers of 2 lots on 9/12/03 instructing them to cease using the recalled lots and to inform the attending physician of any patients diagnosed using these lots. Distributors were asked to forward the letter to all customers who had received CoaguChek test strips or system care products. A copy of the recall notification was sent to the entire professional customer list reminding them to always inspect the product for seal integrity. The recall was extended to all lots via 9/26/03 press release. Recall letters were sent to all professional and home users on or about 10/1/03 advising them to inspect the package seal, to run each sample twice (with two test strips). Home users were asked to notify their physician of the problem.
- Quantity
- 363628
- Distribution
- United States, Australia, Austria, Belgium, Chile, Czech Republic, Greece, Germany, Hungary, Israel, Italy, Netherlands, New Zealand, Poland, Romania, Slovenia, South Africa, Spain, Sweden, Switzerland and the United Kingdom.
- Lot, serial or model codes
- Catalog number 3116247 , Lots 591 and 619; Catalog # 1937642, Lot 600; and Catalog # 1937634, Lot 583. Extended to all lots with an expiration date of on or before March 1, 2005.
- 510(k) numbers
- ["K962571","K974569"]
- PMA numbers
- not on file
- Product code
- GJS
- 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