Device product
ONETOUCH ULTRASOFT LANCETS 100 COUNT Item Number: 3007788
Z-1937-2021
Product summary
- Event
- Event 87787
- Status
- Ongoing
- Classification
- Class II
- Quantity
- 531 boxes of 100 lancets
- Official record key
device-enforcement:Z-1937-2021
Official wording
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.
Code information: NDC/UPC: 353885393102 All lots numbers shipped from 2/23/201 to 3/10/2021
Distribution pattern: US Nationwide distribution in the states of FL, GA, SC.
Derived failure modes
-
Unknown
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.