Stanbio TDM/Beta-Hydroxybutyrate Linearity Standards, packaged in boxes containing Levels 1-6, 1 x 4 mL each, REF 2450-6
Summary
The FDA issued a Class II for Stanbio TDM/Beta-Hydroxybutyrate Linearity Standards, packaged in boxes containi by MEDLINE INDUSTRIES, LP - Northfield. Reason: The product was stored incorrectly due to improper storage controls which may lead to delayed results..
Details
Source
Device Recall
External ID
Z-0933-2022
Action Date
2022-04-20
Status
Terminated
Category
device
Product Description
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.
Lot/Code Info: Lot numbers 172093, exp. 06/30/2023; 174703, exp. 08/31/2023; and 169141, exp. 04/30/2023.
Quantity Affected: 10 boxes
Reason for Recall
The product was stored incorrectly due to improper storage controls which may lead to delayed results.
Distribution
Distribution was made to AL, FL, NE OH, TX, WA, and WI. There was no foreign/military/government distribution.
Type: Voluntary: Firm initiated
Recall Initiated: 2022-03-08
Company
Northfield, IL
Context & Analysis
This is a Class II recall. Class II recalls indicate that use of or exposure to the product may cause temporary or medically reversible health consequences, or that the probability of serious consequences is remote.
This was one of 137 device recalls issued in the same week, part of 413 device-related FDA actions this month.
MEDLINE INDUSTRIES, LP - Northfield has 822 FDA actions in our database, including 822 recalls.
Frequently Asked Questions
What is a Class II recall?
A Class II recall means the product may cause temporary or medically reversible adverse health consequences, or the probability of serious adverse consequences is remote. Consumers should discontinue use.
What should I do if I have this product?
Stop using the product. Check the product against the specific lot numbers or identifiers listed in the recall. Contact the manufacturer (MEDLINE INDUSTRIES, LP - Northfield) or your retailer for a refund or replacement. If you experienced adverse effects, report them to the FDA via MedWatch.
How often does MEDLINE INDUSTRIES, LP - Northfield have FDA actions?
MEDLINE INDUSTRIES, LP - Northfield has 822 FDA actions in our database, including 822 recalls and 0 device clearances.
Where can I find the official FDA record?
The official record is available on FDA.gov. Search for "Z-0933-2022" on FDA.gov for the full record. You can also use the openFDA API to query this record programmatically.
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