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[Recalled] 3mL 9NC Coagulation Sodium Citrate 3.2%, Item #454334, Greiner Bio-One North America Inc., 4238 Capital Drive, Monroe, NC 28110. Intended Use: Venous blood collection tubes. — Part of the lot received a lower concentration o

recall fda device united-states

This is an official product-safety recall record. Below are the verified details from the issuing authority, in plain language.

Recall details

Product3mL 9NC Coagulation Sodium Citrate 3.2%, Item #454334, Greiner Bio-One North America Inc., 4238 Capital Drive, Monroe, NC 28110. Intended Use: Venous blood collection tubes.
Brand / manufacturerGreiner Bio-One North America, Inc.
Categorydevice
Issuing authorityFDA_DEVICE
ReferenceZ-2154-2012
Country of noticeUnited States
Risk levelClass II
Hazard typerecall
Notice date02 July 2012

Why it was recalled

According to the FDA_DEVICE notice, the identified hazard is: Part of the lot received a lower concentration of citrate solution which may cause falsely lower values for common coagulation tests.

This Class II recall concerns device products distributed in United States and was recorded by FDA_DEVICE. Recalls in this category are published so that owners, retailers, and importers can identify affected units and act quickly.

What to do if you own this product

Check whether your unit is affected and follow the authority's guidance before further use.

Read the full official notice →

Related recalls from Greiner Bio-One North America, Inc.

This page indexes a public government recall notice for reference. We do not sell or verify this product; always confirm the current status on the authority's official site.

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