Summary
The FDA issued a Class II for TEG 5000 Functional Fibrinogen Reagent, Item No. 07-034 by Haemonetics Corporation. Reason: Due to a shift in the citrated blood reference range for a normal population, the ranges stated in the IFU are changing. If the clinician relies solel.
Details
Source
Device Recall
External ID
Z-1310-2022
Action Date
2022-07-06
Status
Terminated
Category
device
Product Description
TEG 5000 Functional Fibrinogen Reagent, Item No. 07-034
Lot/Code Info: UDI-DI: (01)20812747018095 All lots are affected.
Quantity Affected: 3933 kits (US); 2429 kits (OUS)
Reason for Recall
Due to a shift in the citrated blood reference range for a normal population, the ranges stated in the IFU are changing. If the clinician relies solely on affected results in comparison to the normal donor reference range, it could lead to misdiagnosis and incorrect treatment or failure to treat.
Distribution
Domestic distribution US Nationwide.
Type: Voluntary: Firm initiated
Recall Initiated: 2022-04-26
Company
Boston, MA
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 114 device recalls issued in the same week, part of 403 device-related FDA actions this month.
Haemonetics Corporation has 5 FDA actions in our database, including 2 recalls and 3 clearances.
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 (Haemonetics Corporation) or your retailer for a refund or replacement. If you experienced adverse effects, report them to the FDA via MedWatch.
How often does Haemonetics Corporation have FDA actions?
Haemonetics Corporation has 5 FDA actions in our database, including 2 recalls and 3 device clearances.
Where can I find the official FDA record?
The official record is available on FDA.gov. Search for "Z-1310-2022" on FDA.gov for the full record. You can also use the openFDA API to query this record programmatically.
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