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Recall Observatory FDA recall evidence

Device product

Diluent, Stat-Site B-HB, 6x 3ML - Product Usage: Intended to be used with the Stat-Site test strips or KetoSite test cards to dilute specimens containing high levelsof B-hydroxybutrate into the test range.

Z-1407-2021

March 15, 2021

Class II

Product summary

Firm
Medline Industries Inc
Event
Event 87561
Status
Ongoing
Classification
Class II
Quantity
24 each
Official record key
device-enforcement:Z-1407-2021

Official wording

Reason: Possible false negative or false positive results due to the product being compromised during shipment.

Code information: Lot #: 163878, 192821,191991, 160795 Manufacturer number:O202000

Distribution pattern: US Nationwide distribution in the state of Ohio.

Derived failure modes

  • Unknown

    reason.no_named_rule · v1.0.0

    Possible false negative or false positive results due to the product being compromised during shipment.