FDA Device recall Z-0360-2019
CoaguChek¿ XS System Prothrombin time test: CoaguChek XS PT Test 2X24 Strips, Catalog Number: 04625315160
- FDA Device
- Class I
- terminated
- Published 2018-11-14
On 2018-11-14 the FDA classified a Class I recall of CoaguChek¿ XS System Prothrombin time test: CoaguChek XS PT Test 2X24 Strips, Catalog Number: 04625315160 by Roche Diagnostics, citing abnormally high INR test results with the affected CoaguChek test strips.
Read the official FDA Device notice
| Agency | FDA Device |
|---|---|
| Recall number | Z-0360-2019 |
| Classification | Class I |
| Status | terminated |
| Initiated | 2018-09-13 |
| Published | 2018-11-14 |
| Last updated | 2026-09-13 11:54 UTC |
| Company | Roche Diagnostics |
| Distribution | US |
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
Identifiers
| code_info | 1) Catalog Number 04625375160 Lot Numbers authorized for use within the USA: 28124111 28124121 28631911 28631921…1) Catalog Number 04625375160 Lot Numbers authorized for use within the USA: 28124111 28124121 28631911 28631921 28631924 28632021 28632213 28632312 28632412 29415113 29415123 29494221 29494312 29494613 29494711 29778721 29779012 29779213 29779214 30497213 30497311 30497413 30497423 30497515 31404314 31404821 32264116 32264212 32264316 32264317 32264411 32264421 33045913 33046011 33046113 33046312 33046314 33046321 33046322 33449612 33449712 33449723 33449817 2) Catalog Number 04625374160 Lot Numbers authorized for use within the USA: 28124111 28124121 28631911 28631921 28631924 28632021 28632213 28632312 28632412 29415113 29415123 29494221 29494312 29494613 29494711 29778721 29779012 29779213 29779214 30497213 30497311 30497413 30497423 30497515 31404314 31404821 32264116 32264212 32264316 32264317 32264411 32264421 33045913 33046011 33046113 33046312 33046314 33046321 33046322 33449612 334497 |
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Status history
No status changes recorded since RecallRadar first saw this recall on 2026-09-13 11:54 UTC. Current status: terminated.
Source
Official record: https://api.fda.gov/device/enforcement.json?search=recall_number:%22Z-0360-2019%22
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