Device product
Alere Toxicology TABLET, INSTANT BLUING F/DRUGSCREEN Model Number: 7875
Z-1588-2022
Product summary
- Event
- Event 90336
- Status
- Ongoing
- Classification
- Class II
- Quantity
- 1 Btl
- Official record key
device-enforcement:Z-1588-2022
Official wording
Reason: Facility Temperature excursions (from June 2021-August 2021) prior to delivery; exposure to higher temperatures may have impacted product effectiveness. All lots received between 06/01/21-9/30/21.
Code information: GTIN: Unknown All lots received between 7/4/21-9/30/21
Distribution pattern: US Nationwide
Derived failure modes
-
Unknown
Facility Temperature excursions (from June 2021-August 2021) prior to delivery; exposure to higher temperatures may have impacted product effectiveness. All lots received between 06/01/21-9/30/21.