Recall Z-0360-2019— Roche Diagnostics Corporation
Class I · Terminated
Class I FDA medical device recall by Roche Diagnostics Corporation, initiated 2018-09-13, terminated 2020-10-16. It names 4 FDA 510(k) clearances: K180684, K170960, K093460 and 1 more. Product: CoaguChek¿ XS System Prothrombin time test: CoaguChek XS PT Test 2X24 Strips, Catalog Number: 04625315160; CoaguChek XS PT Test 6 Strips, Catalog Number: 04625374160; CoaguChek XS PT Test 24 Tests, Catalog Number: 07797826160;. Reason: Abnormally high INR test results with the affected CoaguChek test strips.
- Recalling firm
- Roche Diagnostics Corporation
- Classification
- Class I
- Status
- Terminated
- Initiated
- 2018-09-13
- Terminated
- 2020-10-16
- Firm location
- Indianapolis, IN, United States
510(k) clearances named in this recall
4 on FDA's record- K180684 — CoaguChek XS Plus System
- K170960 — CoaguChek Vantus System
- K093460 — COAGUCHEK XS PRO SYSTEM
- K071041 — COAGUCHEK XS PLUS SYSTEM
K-numbers as listed on FDA's Recall Enterprise System record for this event (openFDA device/recall k_numbers). The recall may also cover devices cleared under other submissions not named here.
Product description
CoaguChek¿ XS System Prothrombin time test: CoaguChek XS PT Test 2X24 Strips, Catalog Number: 04625315160; CoaguChek XS PT Test 6 Strips, Catalog Number: 04625374160; CoaguChek XS PT Test 24 Tests, Catalog Number: 07797826160;
Reason for recall
Abnormally high INR test results with the affected CoaguChek test strips
Data sourced from openFDA. This site is unofficial and independent of the FDA.