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Recall Observatory FDA recall evidence

Device product

Stanbio TDM/Beta-Hydroxybutyrate Linearity Standards, packaged in boxes containing Levels 1-6, 1 x 4 mL each, REF 2450-604, Medline catalog number S-O2450604, IVD.

Z-0933-2022

March 08, 2022

Class II

Product summary

Firm
MEDLINE INDUSTRIES, LP - Northfield
Event
Event 89801
Status
Terminated
Classification
Class II
Quantity
10 boxes
Official record key
device-enforcement:Z-0933-2022

Official wording

Reason: The product was stored incorrectly due to improper storage controls which may lead to delayed results.

Code information: Lot numbers 172093, exp. 06/30/2023; 174703, exp. 08/31/2023; and 169141, exp. 04/30/2023.

Distribution pattern: Distribution was made to AL, FL, NE OH, TX, WA, and WI. There was no foreign/military/government distribution.

Derived failure modes

  • Unknown

    reason.no_named_rule · v1.0.0

    The product was stored incorrectly due to improper storage controls which may lead to delayed results.