CoaguChek brand PT Test Strips; U.S. catalog number 3116247 (professional use), 3116239 (patient self test), ex-U.S. cat
FDA device recall Z-1293-03 · posted 2003-10-15 · Terminated
Recall details
- Recalling firm
- Roche Diagnostics Corp.
- 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.
- 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.
- Root cause
- Other
- Status
- Terminated
- Product code
- GJS
- Quantity affected
- 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, Switzerlan
- Date initiated
- 2003-09-12
- Date posted
- 2003-10-15
- Date terminated
- 2004-05-11
- Location
- Indianapolis, IN
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Related 510(k) clearances
| Record | Firm | Date |
|---|---|---|
| COAGUCHEK SYSTEM, COAGUCHEK SYSTEM FOR PROTHROMBIN TIME SELF TESTING (K974569) | Boehringer Mannheim Corp. | 1998-01-09 |
| COAGUCHEK PST SYSTEM (K962571) | Boehringer Mannheim Corp. | 1997-04-22 |