Separation Technology Creamatocrit Plus, Catalog Number: 100-146
Summary
The FDA issued a Class II for Separation Technology Creamatocrit Plus, Catalog Number: 100-146 by Stanbio Laboratory, LP. Reason: The device was being marketed as an IVD without a 510(k). Therefore, performance characteristics of these breast milk analyzers have not been adequate.
Details
Source
Device Recall
External ID
Z-0905-2022
Action Date
2022-04-20
Status
Terminated
Category
device
Product Description
Separation Technology Creamatocrit Plus, Catalog Number: 100-146
Lot/Code Info: Sold between 2019 and 2021
Quantity Affected: 50
Reason for Recall
The device was being marketed as an IVD without a 510(k). Therefore, performance characteristics of these breast milk analyzers have not been adequately validated. An erroneous result could lead to sub-optimal nutrition supplementation for patients (infants)
Distribution
US Nationwide Distribution CA, TX, OK, SD, IL, NV, MO, FL, WA, KY, WI, PA, NC, GA, MD, MN
Type: Voluntary: Firm initiated
Recall Initiated: 2022-03-16
Company
Boerne, TX
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 403 device-related FDA actions this month.
Stanbio Laboratory, LP has 7 FDA actions in our database, including 7 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 (Stanbio Laboratory, LP) or your retailer for a refund or replacement. If you experienced adverse effects, report them to the FDA via MedWatch.
How often does Stanbio Laboratory, LP have FDA actions?
Stanbio Laboratory, LP has 7 FDA actions in our database, including 7 recalls and 0 device clearances.
Where can I find the official FDA record?
The official record is available on FDA.gov. Search for "Z-0905-2022" on FDA.gov for the full record. You can also use the openFDA API to query this record programmatically.
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