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].
This recall has been terminated (originally issued October 15, 2003).
- Company
- Roche Diagnostics Corp.
- Recall Initiated
- September 12, 2003
- Posted
- October 15, 2003
- Terminated
- May 11, 2004
- Recall Number
- Z-1293-03
- Quantity
- 363628
- Firm Location
- Indianapolis, IN
- Official Source
- View on FDA website ↗
Reason for Recall
Erroneous patient results: may be falsely elevated or lowered, due to a packaging defect that allows air and moisture to enter the sealed pouch.
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 / Code Info
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.
Root Cause
Other
Action Taken
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.