FDA Device recall Z-1938-2021
ONETOUCH ULTRA TEST STRIPS 25 COUNT Item Number: 3510443
- FDA Device
- Class II
- ongoing
- Published 2021-06-30
On 2021-06-30 the FDA classified a Class II recall of ONETOUCH ULTRA TEST STRIPS 25 COUNT Item Number: 3510443 by Cardinal Health, citing due to shipping delays the devices were exposed to temperature excursions of 31.9¿F, intermittently over a 2 hour and 15 minute period of time which may cause inaccurate results.
Read the official FDA Device notice
| Agency | FDA Device |
|---|---|
| Recall number | Z-1938-2021 |
| Classification | Class II |
| Status | ongoing |
| Initiated | 2021-03-16 |
| Published | 2021-06-30 |
| Last updated | 2026-09-13 11:56 UTC |
| Company | Cardinal Health |
| Distribution | US |
Product
ONETOUCH ULTRA TEST STRIPS 25 COUNT Item Number: 3510443
Reason
Due to shipping delays the devices were exposed to temperature excursions of 31.9¿F, intermittently over a 2 hour and 15 minute period of time which may cause inaccurate results.
Identifiers
| upc | 353885994255 |
|---|---|
| code_info | NDC/UPC: 353885994255 All lots numbers shipped from 2/23/201 to 3/10/2021 |
Status history
No status changes recorded since RecallRadar first saw this recall on 2026-09-13 11:56 UTC. Current status: ongoing.
Source
Official record: https://api.fda.gov/device/enforcement.json?search=recall_number:%22Z-1938-2021%22
RecallRadar indexes public recall notices from the FDA, USDA FSIS, and CPSC. The official agency notice is the authoritative source. Always confirm details at the linked source before acting.