Device product
SPIFE ImmunoFix-6 Kit, Cat. No. 3401, 3401T, For In-Vitro Diagnostic Use. The firm name on the label is Helena Laboratories, Beaumont, TX.
Z-0045-2020
Product summary
- Event
- Event 83622
- Status
- Terminated
- Classification
- Class II
- Quantity
- 24 kits
- Official record key
device-enforcement:Z-0045-2020
Official wording
Reason: The plates do not have wells punched for the controls in the patient 1 area.
Code information: Lot 35-17-552583, exp. date 4/30/2018
Distribution pattern: Distribution was made to IN, KY, MA, OH, OR, TN, and TX. There was government distribution. Foreign distribution was made to Chile.
Derived failure modes
-
Unknown
The plates do not have wells punched for the controls in the patient 1 area.