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Haemonetics Corporation FDA Recalls

2 recalls on file across devices, 0 of them Class I and 0 still open. Matched by name to HAE.

Newest first

Class I is the FDA's most serious grade: a reasonable probability of serious harm or death.

Product
TEG 5000 Functional Fibrinogen Reagent, Item No. 07-034Class IIApr 26, 2022Due to a shift in the citrated blood reference range for a n
Product Name: TEG5000 Analyzer (07-022, 07-033) with TEG Analytical Software (07-030, 07-031) and TEG Platelet Mapping AClass IIApr 19, 2022When the TEG 5000 Analyzer including TEG Analytical Software

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